ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS — CORT-HEPAT  

Acute Hepatitis Clinical Trial

Official title: ASSESSMENT OF ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS USING CONCENTRATION OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Hepatitis
• Hepatitis
• Hepatitis A

• NCT number: NCT02859584
• Study type: Interventional
• Source: Centre Hospitalier Universitaire de Besancon
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Completion date: February 2014