- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02859584
ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS (CORT-HEPAT)
ASSESSMENT OF ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS USING CONCENTRATION OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
A high frequency of adrenal dysfunction (AD) has been reported in severe acute hepatitis (SAH) using the dosage of serum total cortisol (STC). Because 90% of circulating serum cortisol is bound to proteins that are altered in SAH, we aimed to investigate the effect of decreased cortisol-binding proteins on STC, serum free cortisol (SFC) and salivary cortisol (SalivCort) in SAH.
Baseline (T0) and cosyntropin-stimulated (T60) STC, SFC and SalivCort concentrations were measured
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We prospectively and consecutively enrolled 75 patients suffering from a SAH (n=44) or a NSAH (n=31). Inclusion criteria were patients aged between 18 and 75 years with an acute hepatitis defined by an abrupt rise in serum aminotransaminase levels during the 15 previous days (AST or ALT greater than 500 IU/L or greater than 10 times the upper normal value); the acute hepatitis was considered as severe if the prothrombin index was lower than 50% and as non-severe if it was greater than 50%. We excluded patients with the following conditions: a history of hypothalamic-pituitary or adrenal disease, corticosteroids treatment within the previous 6 months, ketoconazole intake, oral candida infection, any visible bleeding in the oral cavity, liver transplanted patients, acute alcoholic hepatitis and night workers. Twenty-nine healthy controls (HC) were thereafter enrolled and similarly distributed with the SAH group on age, sex and estrogen pill intake, estrogen therapy being the most common cause for changes in CBG levels. HC were without any known illnesses and were not receiving any medications. To evaluate the range of the SFC concentrations, eight patients with a known AD caused by impairment of hypothalamic-pituitary-adrenal axis (n=5) and adrenal gland (n=3) and followed at the Endocrinology Department of Besancon were also studied.
STC, SFC and salivary cortisol concentrations were measured blindly before (T0 between 8am and 9am) and 60 minutes after (T60) an intravenous injection of 250 µg tetracosactrin (synacthenÒ, Sigma-Tau laboratory, France). Serum CBG, albumin and ACTH were also measured
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inclusion of 101 test subjects and for statistical analysis:
- 29 patients with non-acute severe hepatitis (TP> 50% and AST or ALT> 500 IU / L or> 10 xN for less than 15 days).
- 43 patients with severe acute hepatitis (TP <50%). Patients with suspected IS with the assay of the CTS will retested at Synacthène 4 to 6 months later (10 desired subjects).
- 29 healthy volunteers (control group included in the analysis).
- Inclusion of 10 patients with established IS (control group to estimate the low values of cortisol).
- Patient who signed the consent of study participation
Exclusion Criteria:
- Women during pregnancy or breastfeeding
- Minor and over 75 years
- Major protected within the meaning of Huriet
- Subject healthy volunteers in a sport competition
- Patients transplanted, HIV infection (also refusing HIV status) or patients on immunosuppressive therapies (including corticosteroids)
- ketoconazole Shot, rifampicin, mifepristone, megestrol or etomidate
- Treatment with corticosteroids irrespective of the route of administration
- severe acute alcoholic hepatitis
- oral fungal infection
- upper gastrointestinal bleeding or oral bleeding (contamination salivettes)
- unbalanced Diabetes
- unbalanced Hypertension
- Chronic heart failure (stage III or IV of the classification of the New York Heart Association [NYHA])
- Inability to receive clear information in patients with severe encephalopathy and do not have someone you trust
- Refusal of the participation agreement by signing the form of information and consent as defined in the protocol.
- exclusion period from another biomedical study
- Septic shock
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Healthy volunteers
|
|
Other: no serious acute hepatitis
|
|
Other: Serious acute hepatitis
|
|
Other: Surrenal insufficiency
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Concentration of the serum total cortisol (STC) in SAH.
Time Frame: 2 years
|
2 years
|
Concentration of the serum free cortisol (SFC) in SAH.
Time Frame: 2 years
|
2 years
|
Concentration of the salivary cortisol (SalivCort) in SAH.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Liver Diseases
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Anti-Inflammatory Agents
- Hydrocortisone
- Hydrocortisone 17-butyrate 21-propionate
- Hydrocortisone acetate
- Hydrocortisone hemisuccinate
Other Study ID Numbers
- 2011-A00385-36
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Hepatitis
-
University of Maryland, BaltimoreAlexandria University; MADAUS GmbH; The Egyptian Company for Blood Transfusion... and other collaboratorsTerminatedAcute Hepatitis C | Acute Hepatitis B | Acute Hepatitis A | Acute Hepatitis E | Acute EBV Hepatitis | Acute CMV HepatitisEgypt
-
Sir Ganga Ram HospitalUnknownAcute on Chronic Liver Failure | Acute Severe Viral HepatitisIndia
-
First Affiliated Hospital Xi'an Jiaotong UniversityCompletedHepatitis B, Chronic | Acute-on-Chronic Liver FailureChina
-
Vital Therapies, Inc.CompletedChronic Hepatitis | Acute HepatitisUnited States
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruitingAcute-On-Chronic Liver Failure | Hepatitis B, ChronicChina
-
Xiangya Hospital of Central South UniversityCompletedChronic-on-acute Liver FailureChina
-
Vital Therapies, Inc.CompletedAcute On Chronic HepatitisUnited States, United Kingdom
-
Medical University of ViennaUnknownAcute Liver Failure | Hypoxic Hepatitis | Ischemic Hepatitis | Shock Liver | Hypoxic Liver InjuryGermany, Austria
-
Conatus Pharmaceuticals Inc.TerminatedLiver Cirrhosis | Acute on Chronic Hepatic Failure | Acute Liver Failure | Acute Alcoholic HepatitisUnited States, United Kingdom
-
GlaxoSmithKlineCompletedHepatitis | Acute Hepatitis APanama
Clinical Trials on Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
-
Maastricht Radiation OncologyMaastricht University Medical CenterRecruitingGlioblastoma (GBM)Netherlands
-
Assiut UniversityNot yet recruiting
-
University of MessinaCompleted
-
University of MessinaCompleted
-
Fundación Investigación Sanitaria en LeónCompletedEndometrial Neoplasm MalignantSpain
-
Institut National de la Santé Et de la Recherche...Active, not recruitingBorderline Personality Disorder | Adolescent DevelopmentFrance
-
Assiut UniversityCompletedAnemia of PregnancyEgypt
-
Emory UniversityChildren's Healthcare of AtlantaTerminatedCongenital Heart DiseaseUnited States
-
Sanofi Pasteur, a Sanofi CompanyCompleted
-
Institut Universitari DexeusCompletedCircadian Rhythm | Controlled Ovarian Stimulation | Oocyte Donors | Progesterone Variation on Trigger DaySpain