ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS (CORT-HEPAT)

August 18, 2016 updated by: Centre Hospitalier Universitaire de Besancon

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

Completed

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

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
Other: no serious acute hepatitis
Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
Other: Serious acute hepatitis
Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
Other: Surrenal insufficiency
Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL

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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.

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