NCT02859584

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
Last Updated

August 19, 2016

Status Verified

July 1, 2016

Enrollment Period

2.5 years

First QC Date

July 28, 2016

Last Update Submit

August 18, 2016

Conditions

Acute Hepatitis

Keywords

Acute hepatitisacute liver failureadrenal dysfunctionsalivary cortisolserum free cortisol

Outcome Measures

Primary Outcomes (3)

  • Concentration of the serum total cortisol (STC) in SAH.

    2 years

  • Concentration of the serum free cortisol (SFC) in SAH.

    2 years

  • Concentration of the salivary cortisol (SalivCort) in SAH.

    2 years

Study Arms (4)

no serious acute hepatitis

OTHER
Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL

Serious acute hepatitis

OTHER
Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL

Healthy volunteers

OTHER
Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL

Surrenal insufficiency

OTHER
Biological: Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL

Interventions

Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOLBIOLOGICAL
Healthy volunteersSerious acute hepatitisSurrenal insufficiencyno serious acute hepatitis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with non-acute severe hepatitis (TP\> 50% and AST or ALT\> 500 IU / L or\> 10 xN for less than 15 days).
  • 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).
  • healthy volunteers (control group included in the analysis).
  • Patient who signed the consent of study participation

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 9, 2016

Study Start

August 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

August 19, 2016

Record last verified: 2016-07