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Hormone · Profile

Cortisol

Hydrocortisone · Compound F · Cortef

Adrenal HormonesApproved
MW
362.5g/mol
Formula
C21H30O5

Cortisol, a glucocorticoid hormone produced by the adrenal cortex, plays a crucial role in regulating various physiological processes, including metabolism and the body's response to stress. Researchers primarily study cortisol to understand its impact on health, particularly in relation to the hypothalamo-pituitary-adrenal (HPA) axis and its circadian rhythm. Key findings indicate that disruptions in cortisol levels are associated with conditions such as sleep disturbances, obesity, and increased mortality in patients with adrenal insufficiency. Clinical evidence suggests that restoring a physiological cortisol rhythm may improve quality of life for these patients and reduce complications in vulnerable populations, such as preterm infants at risk for bronchopulmonary dysplasia. Current research is focused on developing innovative glucocorticoid replacement therapies that mimic the natural cortisol rhythm to enhance patient outcomes.

Overview

Übersicht

Cortisol, also known as hydrocortisone, Compound F, or Cortef, is an endogenous glucocorticoid hormone produced by the adrenal cortex. It belongs to the steroid hormone class and is synthesized from cholesterol. Cortisol plays a crucial role in various physiological processes, including metabolism, immune response modulation, and stress response. Researchers have observed that cortisol is involved in maintaining circadian rhythms, influencing sleep patterns, and regulating metabolic functions. It is also a focus of research in conditions such as adrenal insufficiency, bronchopulmonary dysplasia in preterm infants, and inflammatory disorders. Cortisol exerts its effects by binding to glucocorticoid receptors, which then translocate to the nucleus and regulate gene expression. This interaction influences numerous biological pathways, including those involved in glucose metabolism, immune response, and inflammation control. Pharmacokinetically, cortisol has a circulating half-life of approximately 70 minutes and is metabolized primarily in the liver. Its bioavailability varies by route of administration, with oral forms subject to first-pass metabolism. Clinically, cortisol and its synthetic forms are used in the treatment of adrenal insufficiency, inflammatory conditions, and certain pediatric disorders. It is regulated as a prescription medication in many countries, with specific formulations approved for different therapeutic uses. Researchers have found that modified-release formulations, such as Chronocort, aim to mimic the natural circadian rhythm of cortisol, potentially improving patient outcomes in adrenal insufficiency.

Chemical profile

Chemische Struktur

Chemical structure of Cortisol
FormelC21H30O5
Molekulargewicht362.5g/mol
CAS-Nummer50-23-7
PubChem CID5754
Mechanism

Wirkmechanismus

Cortisol acts primarily on glucocorticoid receptors, which are intracellular receptors that, upon binding cortisol, translocate to the cell nucleus and influence gene transcription. This action modulates numerous biological processes, including inflammation, immune response, and metabolism.

Mechanism

Signalweg

Cortisol exerts its effects primarily through the glucocorticoid receptor (GR), which, upon binding, translocates to the nucleus and regulates gene expression by interacting with glucocorticoid response elements (GREs). This action influences various signaling pathways, including the modulation of the HPA axis and the cAMP/PKA pathway, leading to anti-inflammatory responses, metabolic regulation, and circadian rhythm synchronization. While the precise mechanisms of cortisol's action in all tissues are not fully understood, its role as a secondary messenger in linking the central clock to peripheral clocks is well established.

Half-Life & Pharmacokinetics

ENEndogenous

Circulating half-life ~70 minutes

IVIntravenous

~10 minutes

POOral

Poor bioavailability due to first-pass metabolism

Modified-release formulations like Chronocort are designed to mimic natural cortisol rhythms.

Storage

Temperature

Store at room temperature (15-30C)

Light

Protect from light

Form

Aqueous solution: use within specified time after opening

Notes

Ensure proper sealing to prevent contamination.

Solubility

Löslichkeit

Cortisol is poorly soluble in water but soluble in ethanol and other organic solvents.

Legal Status

🇩🇪DE

Verschreibungspflichtig (prescription only); not a controlled substance under BtMG.

🇺🇸US

FDA approved for various indications; prescription required; not a controlled substance.

🇦🇺AU

TGA Schedule 4 (prescription only medicine).

🇬🇧UK

Prescription only medicine (POM) under MHRA regulations.

Legal status information is provided for general reference only and may not reflect the most current regulatory changes. Always verify with official government sources before making any decisions.

Open Questions

Offene Forschungsfragen

Current evidence is limited regarding the long-term effects of physiological glucocorticoid replacement therapies, such as Chronocort and Plenadren, on quality of life and metabolic outcomes in diverse populations, particularly in pediatric patients with adrenal insufficiency. Further research is needed to conduct larger randomized controlled trials (RCTs) to assess the efficacy and safety of low-dose hydrocortisone in preventing bronchopulmonary dysplasia in extremely preterm infants, as well as to explore the underlying mechanisms linking cortisol rhythm disruptions to various psychological and metabolic disorders. Additionally, studies investigating the impact of circadian rhythm restoration on cortisol-related health outcomes in shift workers and other populations experiencing chronic stress are warranted.

109 Research Publications

2,779

Total Citations

66

Human/RCT

2.3

Avg. Influence

2023

Latest

Sort
Filter
#01

Modified-release hydrocortisone to provide circadian cortisol profiles.

HumanInfluence6.0
295
Researchers observed that modified-release hydrocortisone can replicate physiological cortisol levels more effectively than immediate-release formulations, addressing the unmet clinical need for better glucocorticoid replacement.
#02

Replication of cortisol circadian rhythm: new advances in hydrocortisone replacement therapy.

UnknownInfluence4.0
232
Researchers observed that novel hydrocortisone formulations may replicate the physiological circadian rhythm of cortisol, potentially improving quality of life for patients with adrenal insufficiency.
#03

The detection of cortisol in human sweat: implications for measurement of cortisol in hair.

HumanInfluence2.0
164
The study demonstrated that sweat cortisol concentrations correlate with salivary cortisol levels and can influence hair cortisol measurements.
#04

An oral multiparticulate, modified-release, hydrocortisone replacement therapy that provides physiological cortisol exposure.

In VitroInfluence1.0
122
The study demonstrated that a multiparticulate oral hydrocortisone formulation provides physiological cortisol exposure, achieving a cortisol profile similar to that of healthy individuals.
#05

Acute effects of hydrocortisone on the human brain: an fMRI study.

HumanInfluence4.0
122
Researchers observed reduced activity in the hippocampus and amygdala in healthy humans following intravenous hydrocortisone administration, indicating its acute effects on brain activity.
#06

Salivary Cortisone Reflects Cortisol Exposure Under Physiological Conditions and After Hydrocortisone.

In VitroInfluence4.0
112
The study demonstrated that salivary cortisone is a reliable indicator of serum cortisol exposure under physiological conditions and during hydrocortisone therapy.
#07

Salivary cortisol and cortisone in the clinical setting.

Blair Joanne, et al. · Current opinion in endocrinology, diabetes, and obesity · 2017

ReviewInfluence7.0
105
The review highlights that salivary cortisone is a superior marker for assessing adrenal function compared to salivary cortisol, especially during hydrocortisone therapy.

Key findings

  1. 01Salivary measurements detect only free hormones and can be taken easily during daily routines.
  2. 02Salivary cortisone is a better marker than salivary cortisol for low serum cortisol levels.
  3. 03Salivary biomarkers are more accurate for assessing adrenal reserve compared to serum cortisol.
#08

Bioavailability of oral hydrocortisone in patients with congenital adrenal hyperplasia due to 21-hydroxylase deficiency.

Case ReportInfluence5.0
100
The study demonstrated that the bioavailability of oral hydrocortisone is high in pediatric patients with congenital adrenal hyperplasia, potentially leading to supraphysiological cortisol concentrations.
#09

Exogenous cortisol exerts effects on the startle reflex independent of emotional modulation.

HumanInfluence11.0
99
The study demonstrated that exogenous cortisol modulates the acoustic startle reflex in a biphasic manner, independent of emotional modulation, with varying effects based on dosage.
#10

Prevalence of low cortisol values in term and near-term infants with vasopressor-resistant hypotension.

Case ReportInfluence2.0
82
The study demonstrated that a significant proportion of term and near-term infants with vasopressor-resistant hypotension exhibit low cortisol levels, and hydrocortisone therapy improved hemodynamic stability.

Clinical Trials (104)

Preclinical
Phase I
Phase II
Phase III
Approved

104

Total Trials

38,278

Total Enrolled

Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants

NCT06515405ACTIVE_NOT_RECRUITING
Sponsor

Imperial College London

Enrollment

16,000

Started

2024

Primary outcome

Gastrointestinal (GI) perforation

Intestinal Perforation

Days Alive and Out of Hospital for Patients With Sepsis

NCT04567433COMPLETED
Sponsor

The George Institute for Global Health, Australia

Enrollment

6,213

Started

2020

Primary outcome

Quality of Life as measured by the EQ5D

SepsisSeptic Shock

Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS

NCT01540812COMPLETED
Sponsor

PETHEMA Foundation

Enrollment

418

Started

2012

Primary outcome

Overall response rate

Acute Lymphoblastic Leukemia

Early Intravenous Hydrocortisone in Sepsis

NCT06217939RECRUITING
Sponsor

Siriraj Hospital

Enrollment

230

Started

2024

Primary outcome

28-day mortality

Sepsis SevereShock, Septic

Applied Social Neuroscience: the Building Resilience Among Women Project

Sponsor

Ximena Goldberg

Enrollment

172

Started

2019

Primary outcome

Salivary cortisol

Violence, DomesticStress Related DisorderDepressive Disorder

Comparison Between Intravenous Hydrocortisone and Ondansetron in Prevention of Post Spinal Anesthesia Hypotension

NCT06930456ENROLLING_BY_INVITATION
Sponsor

Nada kamel Elgamal

Enrollment

120

Started

2024

Primary outcome

hypotension

Post Spinal Anaesthesia Hypotension

Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest

NCT00172354COMPLETED
Sponsor

National Taiwan University Hospital

Enrollment

100

Started

2004

Heart Arrest

Neurocognitive Function After Regional and General Anesthesia (245_14 B)

NCT02505815COMPLETED
Sponsor

University of Erlangen-Nürnberg Medical School

Enrollment

80

Started

2014

Primary outcome

Neurocognitive Function

Neurocognitive Function

Thiamine As An Adjuvant Therapy For Hyperlactatemia In Septic Shock Patients

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Enrollment

72

Started

2018

Primary outcome

Assessment of the relative lactate level change over 24 hours

Hyperlactatemia

Organ Donation and Hydrocortisone Treatment

NCT00675272TERMINATED
Sponsor

Kuopio University Hospital

Enrollment

38

Started

2008

Primary outcome

dosage and time on norepinephrine treatment

Brain Death

The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation

NCT00688987COMPLETED
Sponsor

Oregon Health and Science University

Enrollment

24

Started

2000

Primary outcome

Amounts of intra-abdominal fat and total fat at the end of the treatment period for each cortisol dose.

ObesityAddison's Disease

Mindfulness Based Couples Therapy

NCT02349217COMPLETED
Sponsor

M.D. Anderson Cancer Center

Enrollment

24

Started

2015

Primary outcome

Feasibility of Mindfulness Based Couples Therapy Intervention Among Breast Cancer Survivors and Their Partners (intervention adherence rate, defined as the proportion of sessions completed out of a total of 8 sessions)

Breast Cancer

Acute Consequences of Glucocorticoid Secretion in Overweight and Obese Individuals During Maximum Calorie Intake

NCT06556277COMPLETED
Sponsor

Eleonora Seelig

Enrollment

23

Started

2024

Primary outcome

Total body fat

GlucocorticoidsOverweight and ObesityOvereating

Mitochondrial Function in Septic Patients

NCT03748537COMPLETED
Sponsor

Chiang Mai University

Enrollment

20

Started

2017

Primary outcome

To investigate the level of mitochondrial respiration after steroid administration

SepsisSeptic Shock

Low-dose Cortisol in Chronic Posttraumatic Stress Disorder

NCT00362661TERMINATED
Sponsor

University of Zurich

Enrollment

20

Started

2007

Primary outcome

CAPS CGI

Posttraumatic Stress Disorder

Cortisol Augmentation of Prolonged Exposure Therapy

NCT00751855COMPLETED
Sponsor

VISN 3 Mental Illness Research, Education and Clinical Center

Enrollment

11

Started

2008

Primary outcome

Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)

PTSD

Research Study for Children With Salt Wasting Congenital Adrenal Hyperplasia

NCT00529841COMPLETED
Sponsor

Baylor College of Medicine

Enrollment

7

Started

2007

Primary outcome

Serum 17-OHP concentration in the morning

Adrenal Hyperplasia, Congenital

Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery

NCT00442494TERMINATED
Sponsor

Kuopio University Hospital

Enrollment

1

Started

2012

Primary outcome

Study couldn´t start due to investigator

Atrial Fibrillation

Patient Self-administration of Cortisol for Cortisol-responding Disorders in Men and Women Over the Age of 17

NCT03558971Phase 4COMPLETED
Sponsor

Helen Foundation

Enrollment

2,430

Started

2000

Primary outcome

Participant evaluation of disease symptom intensity

Rheumatic Diseases

Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency

NCT05435781Phase 4RECRUITING
Sponsor

Marianne Christina Klose

Enrollment

250

Started

2022

Primary outcome

ecological momentary assessments (EMA) of the Multidimensional Fatigue Inventory (MFI-20) General Fatigue scale, adjusted for EMA

Adrenal InsufficiencyPolymyalgia RheumaticaGiant Cell Arteritis

Influence of Hydrocortisone on Immunologic Markers and Health Care Related Quality of Life in Patients After Cardiac Surgery

NCT00490828Phase 4COMPLETED
Sponsor

Ludwig-Maximilians - University of Munich

Enrollment

120

Started

2007

Primary outcome

immunologic markers, health care related quality of life, PTSD

Systemic Inflammatory Response SyndromePosttraumatic Stress Disorder

Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency

NCT04536662Phase 4UNKNOWN
Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

120

Started

2020

Primary outcome

The number of ovulatory menstruation in female patients

Congenital Adrenal Hyperplasia

An Efficacy and Safety Study of Miconazole and Hydrocortisone Cream in the Treatment of Vulvar Candidiasis

NCT01769339Phase 4COMPLETED
Sponsor

Janssen Pharmaceutica

Enrollment

115

Started

2009

Primary outcome

Mean Time to Itch Relief

Vulva; Candidiasis

Continuous Infusion Versus Intermittent Bolus Hydrocortisone in Septic Shock

NCT07695337Phase 4COMPLETED
Sponsor

Benha University

Enrollment

110

Started

2026

Primary outcome

28-Day All-Cause Mortality

Septic Shock

Treatment of High Risk Adult Acute Lymphoblastic Leukemia

NCT00853008Phase 4COMPLETED
Sponsor

PETHEMA Foundation

Enrollment

100

Started

2003

Primary outcome

To evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels in HR Ph- adult ALL patients.

Acute Lymphoblastic Leukemia

Effect of Treatment With Stress-Doses Glucocorticoid in Patients With Acute Respiratory Distress Syndrome (ARDS)

NCT00773058Phase 4UNKNOWN
Sponsor

Southeast University, China

Enrollment

100

Started

2008

Primary outcome

Evidence of clinically definite ARDS confirmed by AECC criteria in 1994

Acute Respiratory Distress SyndromeAdrenal Insufficiency

Hyperglycemia and Effects of Daily 100 mg Versus 200 mg of Hydrocortisone Therapy in Patients With Septic Shock

NCT02266264Phase 4COMPLETED
Sponsor

Srinakharinwirot University

Enrollment

80

Started

2014

Primary outcome

Hyperglycemia

Hyperglycemia

Vitamin C, Vitamin B1 and Steroid in Sepsis

NCT04039815Phase 4UNKNOWN
Sponsor

Far Eastern Memorial Hospital

Enrollment

80

Started

2019

Primary outcome

The primary endpoint was the hospital survival.

Sepsis, Severe

Effect of Low Dose Corticosteroids on Perioperative Markers of Thrombosis and Fibrinolysis in Total Knee Arthroplasty

NCT01815918Phase 4COMPLETED
Sponsor

Hospital for Special Surgery, New York

Enrollment

60

Started

2011

Primary outcome

Prothrombin Fragment (PF1.2), a Marker of Thrombin Generation

Total Knee Arthroplasty

Ramadan Fasting in Patients With Corticotrope Deficiency Treated Either by Hydrocortisone or by Prednisolone

NCT03585829Phase 4COMPLETED
Sponsor

University Tunis El Manar

Enrollment

53

Started

2018

Primary outcome

Occurence of complications

Corticotropin DeficiencyFasting

Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock

NCT06122987Phase 4UNKNOWN
Sponsor

Kingman Regional Medical Center

Enrollment

50

Started

2023

Primary outcome

The incidence of hemodynamic response, defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 1 hour after initiation of angiotensin-II

Septic ShockShockSepsisSystemic Inflammatory Response Syndrome

Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance

NCT07494084Phase 4NOT_YET_RECRUITING
Sponsor

Washington State University

Enrollment

48

Started

2026

Primary outcome

Insulin resistance-Minimal Model (Si)

Shift Work ScheduleCircadian RhythmInsulin ResistanceCircadian Misalignment

Tapioca Starch Stimutex AS, Aloe Barbadensis, Rose Hip Oil, Allantoin Comparing With Topical 1% Hydrocortisone Cream

NCT04325490Phase 4COMPLETED
Sponsor

Mahidol University

Enrollment

40

Started

2019

Primary outcome

Efficacy of liquid powder containing tapioca starch stimutex AS, aloe barbadensis, rose hip oil and allantoin, compared to topical 1% hydrocortisone cream for the treatment of intertrigo.

Intertrigo

Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics

NCT06435481Phase 4NOT_YET_RECRUITING
Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

35

Started

2024

Primary outcome

Tolerability and acceptance of the two compounded oral hydrocortisone formulations

Adrenal Insufficiency

Reversal of Acute β-Blocker Induced Bronchoconstriction

NCT01070225Phase 4COMPLETED
Sponsor

University of Dundee

Enrollment

14

Started

2010

Primary outcome

To establish whether acute β-blockade influences the ability to achieve airway reversibility and recovery with systemic corticosteroids and nebulised bronchodilators following histamine challenge in mild to moderate asthmatics.

Asthma

Rapid Effects of Hydrocortisone on Glucose-induced Insulin Secretion in Healthy Humans

NCT00709839Phase 4COMPLETED
Sponsor

Medical University of Vienna

Enrollment

10

Started

2008

Primary outcome

Plasma insulin, glucose and C-peptide

Healthy

The Effects of Two Brands of Hydrocortisone Injected Intramuscularly Into Deltoid and Thigh Muscles

NCT05350020Phase 4UNKNOWN
Sponsor

The London Clinic

Enrollment

8

Started

2022

Primary outcome

State of Hypocortisolaemia when injected into deltoid muscle or thigh muscle

Addison's Disease

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

NCT06136650Phase 3RECRUITING
Sponsor

Merck Sharp & Dohme LLC

Enrollment

1,314

Started

2023

Primary outcome

Radiographic Progression-Free Survival (rPFS)

Metastatic Castration-resistant Prostate Cancer (mCRPC)Prostatic Neoplasms

Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds

NCT00691002Phase 3COMPLETED
Sponsor

LEO Pharma

Enrollment

1,245

Started

2008

Primary outcome

Participants With "Controlled Disease" According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase

Psoriasis Vulgaris

Hydrocortisone for BPD

NCT01353313Phase 3COMPLETED
Sponsor

NICHD Neonatal Research Network

Enrollment

800

Started

2011

Primary outcome

Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD)

Infant, NewbornInfant, Small for Gestational AgeInfant, Very Low Birth WeightInfant, PrematureBronchopulmonary Dysplasia

05-001: Treatment of Acute Lymphoblastic Leukemia in Children

NCT00400946Phase 3COMPLETED
Sponsor

Dana-Farber Cancer Institute

Enrollment

800

Started

2005

Primary outcome

Asparaginase-Related Toxicity Rate

Drug/Agent Toxicity by Tissue/OrganLeukemia

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

NCT03020030Phase 3ACTIVE_NOT_RECRUITING
Sponsor

Dana-Farber Cancer Institute

Enrollment

560

Started

2017

Primary outcome

Complete Remission Rate

Acute Lymphoblastic Leukemia, Pediatric

Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock

NCT00320099Phase 3COMPLETED
Sponsor

University of Versailles

Enrollment

508

Started

2006

Primary outcome

In-hospital mortality

Septic Shock

Stress Hydrocortisone In Pediatric Septic Shock

NCT03401398Phase 3RECRUITING
Sponsor

Jerry Zimmerman

Enrollment

500

Started

2019

Primary outcome

New or progressive multiple organ dysfunction syndrome as assessed utilizing the Pediatric Logistic Organ Dysfunction (PELOD-2) instrument.

Septic Shock

Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema

NCT00375713Phase 3COMPLETED
Sponsor

UCB Pharma

Enrollment

466

Started

2005

Primary outcome

Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).

DermatitisEczema

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

NCT03007147Phase 3ACTIVE_NOT_RECRUITING
Sponsor

Children's Oncology Group

Enrollment

352

Started

2017

Primary outcome

Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients)

Acute Lymphoblastic LeukemiaB Acute Lymphoblastic LeukemiaMixed Phenotype Acute LeukemiaT Acute Lymphoblastic Leukemia

Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer

NCT00002855Phase 3COMPLETED
Sponsor

M.D. Anderson Cancer Center

Enrollment

306

Started

1996

Primary outcome

Time to Progression

Prostate Cancer

Combination Chemotherapy Followed By Donor Stem Cell Transplant in Treating Patients With Hemophagocytic Lymphohistiocytosis

NCT00334672Phase 3UNKNOWN
Sponsor

Children's Cancer and Leukaemia Group

Enrollment

288

Started

2006

Primary outcome

Survival

Nonneoplastic Condition

Hydrocortisone Plus Fludrocortisone in High-risk Patients Undergoing for Cardiac Surgery

NCT07037043Phase 3RECRUITING
Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

196

Started

2025

Primary outcome

Variation of acute kidney injury occurence between both groups

Inflammation in Cardiac Surgery

Hydrocortisone Use After Etomidate in Intensive Care

NCT00862381Phase 3COMPLETED
Sponsor

University Hospital, Grenoble

Enrollment

106

Started

2008

Primary outcome

diminution of 50% of the proportion of patients with a score SOFA of 3 or 4

Patient Admitted in Reanimation

Safety and Efficacy of Prednisolone in Adrenal Insufficiency Disease (PRED-AID Study)

NCT03936517Phase 3UNKNOWN
Sponsor

Imperial College London

Enrollment

44

Started

2019

Primary outcome

Change in concentration of Osteocalcin

Adrenal Insufficiency

Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants

NCT00358748Phase 3COMPLETED
Sponsor

University of British Columbia

Enrollment

40

Started

2005

Primary outcome

Total cumulative dose of dopamine at 48 hours of study drug administration and by day 7 of life

Neonatal Hypotension

Vitamin C, Thiamine, Cyanocobalamine, Pyridoxine and Hydrocortisone in Sepsis

NCT04197115Phase 3COMPLETED
Sponsor

IMSS Hospital General de Zona 11, Piedras Negras

Enrollment

19

Started

2019

Primary outcome

Difference in hospital mortality in phase 1 vs phase 2 groups

SepsisSeptic Shock

Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes

NCT00591006Phase 3COMPLETED
Sponsor

University of Texas Southwestern Medical Center

Enrollment

17

Started

2008

Primary outcome

Difference in RAVLT Total T-Score Between Treatments

Healthy

Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer

NCT00027859Phase 3COMPLETED
Sponsor

Eastern Cooperative Oncology Group

Started

2003

Prostate Cancer

Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer

NCT00002881Phase 3COMPLETED
Sponsor

Eastern Cooperative Oncology Group

Started

1996

Prostate Cancer

A Comparative Study of Glucocorticoids Efficacy in Acute Respiratory Distress Syndrome

NCT06496997Phase 2/3RECRUITING
Sponsor

Fayoum University

Enrollment

300

Started

2024

Primary outcome

28-day mortality after enrolment

Acute Respiratory Distress Syndrome

Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial

NCT03389555Phase 2/3COMPLETED
Sponsor

Beth Israel Deaconess Medical Center

Enrollment

205

Started

2018

Primary outcome

Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours

SepsisSeptic ShockMetabolic Disturbance

Treatment of Polytraumatisms With Corticoids

NCT00563303Phase 2/3COMPLETED
Sponsor

Nantes University Hospital

Enrollment

150

Started

2006

Primary outcome

Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria

Polytraumatism

Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency

NCT00915343Phase 2/3COMPLETED
Sponsor

Shire

Enrollment

64

Started

2007

Primary outcome

Area Under the Concentration Time Curve From Zero to 24 Hours (AUC0-24h) of Total S-cortisol in Plasma After Multiple Doses During Part A

Adrenal Insufficiency

Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

NCT00720109Phase 2/3COMPLETED
Sponsor

National Cancer Institute (NCI)

Enrollment

63

Started

2008

Primary outcome

Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy

Acute Lymphoblastic LeukemiaAdult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns

NCT02700828Phase 2/3COMPLETED
Sponsor

Semmelweis University

Enrollment

32

Started

2016

Primary outcome

Compare mean arterial blood pressure (MAP) change in the patients receiving hydrocortisone vs placebo

Hypoxic-Ischemic EncephalopathyAsphyxia

Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone.

NCT05534334Phase 2/3UNKNOWN
Sponsor

Beni-Suef University

Enrollment

30

Started

2022

Primary outcome

Remaining width of the attached gingiva

Oral Pyogenic Granuloma

Steroid, Thiamine and Ascorbic Acid for Comatose Out-of-hospital Cardiac Arrest Survivors

NCT04921189Phase 2COMPLETED
Sponsor

Asan Medical Center

Enrollment

160

Started

2021

Primary outcome

the peak neuron-specific enolase level

Out-Of-Hospital Cardiac ArrestPostcardiac Arrest Syndrome

Early Versus Conventional Cessation of Hydrocortisone in Septic Shock

NCT05818826Phase 2UNKNOWN
Sponsor

Mahidol University

Enrollment

160

Started

2023

Primary outcome

Composite adverse events of early versus conventional cessation of hydrocortisone

Septic ShockAdverse EventHydrocortisoneHyperglycemiaHypernatremiaMuscle WeaknessSuperimposed Infection

Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus

NCT02229136Phase 2COMPLETED
Sponsor

US Oncology Research

Enrollment

104

Started

2014

Primary outcome

Incidence of Grade ≥ 2 stomatitis

StomatitisOral MucositisNeoplasm of the BreastMalignant Tumor of Breast

Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids

NCT03335774Phase 2COMPLETED
Sponsor

Nivagen Pharmaceuticals Inc.

Enrollment

103

Started

2019

Primary outcome

Reduction in Swelling

Internal Hemorrhoids

A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone

NCT05607901Phase 2COMPLETED
Sponsor

Tanta University

Enrollment

100

Started

2022

Primary outcome

To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood.

Dermatologic Disease

Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

NCT06390319Phase 2RECRUITING
Sponsor

St. Jude Children's Research Hospital

Enrollment

100

Started

2024

Primary outcome

Minimal residual disease (MRD)-negativity rate in patients with T cell acute lymphoblastic leukemia

T-cell Acute Lymphoblastic LeukemiaT-cell LymphomaMixed Phenotype Acute Leukemia

Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement

NCT02828358Phase 2COMPLETED
Sponsor

National Cancer Institute (NCI)

Enrollment

78

Started

2017

Primary outcome

Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)

Acute Leukemia of Ambiguous LineageB Acute Lymphoblastic LeukemiaMixed Phenotype Acute Leukemia

Emotional Regulation and Impulsivity Among Adolescents with Borderline Personality Disorder

NCT03209102Phase 2ACTIVE_NOT_RECRUITING
Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrollment

66

Started

2017

Primary outcome

Comparison between subjective and objective acute stress experience in BPD Adolescents vs Healthy controls

Borderline Personality DisorderAdolescent Development

Glucocorticoid Treatment for Social Phobia

NCT01574014Phase 2TERMINATED
Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

66

Started

2009

Primary outcome

Change from baseline in spider phobia symptoms / social phobia symptoms

Phobic DisordersPhobias

Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants

NCT00167544Phase 2COMPLETED
Sponsor

Nationwide Children's Hospital

Enrollment

64

Started

2005

Primary outcome

Total Cerebral Volume as Measured by Volumetric Brain MRI

Bronchopulmonary DysplasiaEncephalomalaciaPremature Birth

Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia

NCT03071276Phase 2TERMINATED
Sponsor

St. Jude Children's Research Hospital

Enrollment

37

Started

2016

Primary outcome

The Overall Response (OR) Rate (Complete Response + Incomplete Count Recovery + Partial Response)

Acute Myeloid Leukemia (AML)

Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

NCT00460031Phase 2COMPLETED
Sponsor

Case Comprehensive Cancer Center

Enrollment

34

Started

2006

Primary outcome

Number of Patients With a Partial Response, Progressive Disease, or Stable Disease Based on Prostate-Specific Antigen (PSA) or Measurable Disease

Prostate Cancer

Ketoconazole and Dexamethasone in Prostate Cancer

NCT01036594Phase 2COMPLETED
Sponsor

University of California, San Francisco

Enrollment

32

Started

2009

Primary outcome

Number of Participants Who Achieved a Second Decline in Prostate Specific Antigen (PSA) Following Progression on First Regimen

Prostate Cancer

Hybrid Immunotherapy for Hemophagocytic LymphoHistiocytosis

NCT01104025Phase 2COMPLETED
Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

31

Started

2010

Primary outcome

Overall Survival

Hemophagocytic Lymphohistiocytosis

Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children Study

NCT05276323Phase 2COMPLETED
Sponsor

Soroka University Medical Center

Enrollment

30

Started

2020

Primary outcome

response rate

Atopic Dermatitis

Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy

NCT00895310Phase 2COMPLETED
Sponsor

University of California, Davis

Enrollment

30

Started

2009

Primary outcome

Prostate Specific Antigen (PSA) Response (>50% Reduction From Baseline)

Prostate Cancer

Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT

NCT00084838Phase 2COMPLETED
Sponsor

Dana-Farber Cancer Institute

Enrollment

25

Started

2003

Primary outcome

2-yr Overall Survival

Central Nervous System Tumor, Pediatric

High-Intensity, Brief-Duration Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia

NCT00002865Phase 2COMPLETED
Sponsor

Wake Forest University Health Sciences

Enrollment

25

Started

1995

Primary outcome

response rate for patients with relapsed or refractory acute lymphoblastic leukemia after brief, high intensity chemotherapy

Leukemia

Evaluation of Corticosteroid Therapy in Childhood Severe Sepsis - a Randomised Pilot Study

NCT00732277Phase 2COMPLETED
Sponsor

University Hospital Southampton NHS Foundation Trust

Enrollment

21

Started

2008

Primary outcome

primary efficacy endpoint is all cause mortality

Sepsis

Effects of Pharmacological Stress and rTMS on Executive Function in Opioid Use Disorder

NCT04231708Phase 2NOT_YET_RECRUITING
Sponsor

Wayne State University

Enrollment

20

Started

2026

Primary outcome

Color-Word Stroop Task

Opioid Use Disorder

Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis

NCT01860664Phase 2TERMINATED
Sponsor

Koffler Vision Group

Enrollment

15

Started

2013

Primary outcome

Efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis

Allergic Conjunctivitis

Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG

NCT00899847Phase 2COMPLETED
Sponsor

Stanford University

Enrollment

9

Started

2009

Primary outcome

Incidence of Graft Versus Host Disease (GvHD)

Transplantation, HomologousTransplantation, AutologousMultiple MyelomaBlood and Marrow Transplant (BMT)

Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)

NCT00098839Phase 1/2COMPLETED
Sponsor

Children's Oncology Group

Enrollment

134

Started

2005

Primary outcome

Remission Re-induction (CR2) Rate

Recurrent Childhood Acute Lymphoblastic Leukemia

Physiologic Effects of Steroids in Cardiac Arrest

NCT02790788Phase 1/2COMPLETED
Sponsor

University of Athens

Enrollment

100

Started

2016

Primary outcome

Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).

Inhospital Cardiac Arrest

Combination Chemotherapy, Rituximab, and Ixazomib Citrate in Treating Patients With Non-Hodgkin Lymphoma

NCT02481310Phase 1/2UNKNOWN
Sponsor

Northwestern University

Enrollment

38

Started

2015

Primary outcome

To Determine the Recommended Phase II Dose (RP2D) of Ixazomib in Combination With DA-EPOCH-R.

Adult Burkitt LymphomaB-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt LymphomaDiffuse Large B-Cell LymphomaMYC Gene MutationPlasmablastic Lymphoma

Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression

NCT00673270Phase 1/2TERMINATED
Sponsor

Rennes University Hospital

Enrollment

13

Started

2008

Primary outcome

Phenylephrine-mean arterial pressure dose-response relationship

Renin Angiotensin

Glucocorticoid Administration After Traumatic Birth

NCT04852458Phase 1COMPLETED
Sponsor

University of Michigan

Enrollment

133

Started

2021

Primary outcome

PTSD assessed by the City Birth Trauma Scale

Traumatic Birth

Topical Cream SNG100 for Treatment in Moderate Atopic Dermatitis Subjects.

NCT04615962Phase 1UNKNOWN
Sponsor

Seanergy Dermatology Ltd.

Enrollment

66

Started

2021

Primary outcome

Side Effects AE's and SAE's

Atopic Dermatitis

Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies

NCT05476770Phase 1RECRUITING
Sponsor

Therapeutic Advances in Childhood Leukemia Consortium

Enrollment

54

Started

2022

Primary outcome

Occurrence of dose limiting toxicity (DLT) during cycle 1 of therapy

Hematologic MalignancyAMLALLBPDCNMDSLymphoblastic LymphomaLymphoma, B-CellLymphoma, T-CellHodgkin LymphomaMixed Phenotype Acute LeukemiaAcute Undifferentiated Leukemia

A Study of Infacort® Versus Cortef® in Healthy Adult Male and Female Subjects

NCT03311932Phase 1COMPLETED
Sponsor

Neurocrine UK Limited

Enrollment

51

Started

2018

Primary outcome

Pharmacokinetic parameters for serum cortisol - Maximum serum concentration (Cmax)

Adrenal Insufficiency

Venetoclax Basket Trial for High Risk Hematologic Malignancies

NCT05292664Phase 1RECRUITING
Sponsor

Andrew E. Place, MD

Enrollment

30

Started

2023

Primary outcome

Maximum tolerated dose (MTD)

Myelodysplastic Syndromes, de NovoMyelodysplastic Syndromes, SecondaryMyelodysplastic Syndromes, Previously TreatedTreatment-Related Acute Myeloid LeukemiaTherapy-Related Myelodysplastic SyndromeAcute Lymphoblastic Leukemia, in RelapseAcute Lymphoblastic Leukemia With Failed RemissionLymphoblastic Lymphoma, in RelapseLymphoblastic Lymphoma, RefractoryAcute Leukemia of Ambiguous Lineage in RelapseAcute Leukemia of Ambiguous Lineage

A Study of Chronocort® Versus Cortef ® in Healthy Adult Male Subjects

NCT03343327Phase 1COMPLETED
Sponsor

Neurocrine UK Limited

Enrollment

25

Started

2018

Primary outcome

Area under the concentration time curve from time 0 to infinity (AUC0-inf) of Chronocort® to Cortef® based on baseline adjusted and unadjusted serum cortisol concentration calculated for each sampling time point.

Adrenal Insufficiency

Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Suppositories

NCT02671058Phase 1COMPLETED
Sponsor

Cristcot LLC

Enrollment

16

Started

2016

Primary outcome

primary PK endpoints

Healthy

An Investigational Study of Hydrocortisone

NCT01960530Phase 1COMPLETED
Sponsor

Neurocrine UK Limited

Enrollment

14

Started

2013

Primary outcome

Maximum Serum Concentration (Cmax)

Adrenal Insufficiency

Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

NCT03792256Phase 1COMPLETED
Sponsor

Children's Oncology Group

Enrollment

12

Started

2019

Primary outcome

Frequency of Dose Limiting Toxicities of Palbociclib

Leukemia, LymphocyticLymphoblastic LymphomaT-cell LymphomaT-cell LeukemiaRecurrent DiseaseAcute Leukemia

Early Blood Pressure Management in Extremely Premature Infants

NCT00874393Phase 1COMPLETED
Sponsor

NICHD Neonatal Research Network

Enrollment

10

Started

2009

Primary outcome

Enrollment and completion of 60 infants

Infant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, PrematureHypotensionBlood Pressure

Pevonedistat With VXLD Chemotherapy for Adolescent/Young Adults With Relapsed/Refractory ALL or Lymphoblastic NHL

NCT03349281Phase 1COMPLETED
Sponsor

Julio Barredo, MD

Enrollment

6

Started

2019

Primary outcome

Rate of Toxicity in Study Participants Receiving Protocol Therapy

Refractory Acute Lymphoblastic LeukemiaRelapsed Acute Lymphoblastic Leukemia

EZN-3042 Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL)

NCT01186328Phase 1TERMINATED
Sponsor

Therapeutic Advances in Childhood Leukemia Consortium

Enrollment

6

Started

2010

Primary outcome

Maximum Tolerated Dose of EZN-3042

Lymphoblastic Leukemia, AcuteLymphoblastic Leukemia, Acute, ChildhoodLeukemia, Lymphoblastic, Acute, T CellLeukemia, Lymphoblastic, Acute

Combined Use of Dexmedetomidine and Hydrocortisone to Prevent New Onset AF After CABG Surgery

NCT05674253Early Phase 1UNKNOWN
Sponsor

Ain Shams University

Enrollment

248

Started

2022

Primary outcome

Occurrence of AF

Atrial Fibrillation New Onset

The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression

NCT02837432Early Phase 1COMPLETED
Sponsor

Stanford University

Enrollment

192

Started

2016

Primary outcome

Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.

Depression

CRF - Nociceptin Receptor Interactions

NCT03302416Early Phase 1COMPLETED
Sponsor

University of Pittsburgh

Enrollment

19

Started

2016

Primary outcome

[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration

Healthy

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