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

Primary Purpose

Acute Hepatitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Hepatitis focused on measuring Acute hepatitis, acute liver failure, adrenal dysfunction, salivary cortisol, serum free cortisol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    no serious acute hepatitis

    Serious acute hepatitis

    Healthy volunteers

    Surrenal insufficiency

    Arm Description

    Outcomes

    Primary Outcome Measures

    Concentration of the serum total cortisol (STC) in SAH.
    Concentration of the serum free cortisol (SFC) in SAH.
    Concentration of the salivary cortisol (SalivCort) in SAH.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 28, 2016
    Last Updated
    August 18, 2016
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02859584
    Brief Title
    ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS
    Acronym
    CORT-HEPAT
    Official Title
    ASSESSMENT OF ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS USING CONCENTRATION OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    February 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Hepatitis
    Keywords
    Acute hepatitis, acute liver failure, adrenal dysfunction, salivary cortisol, serum free cortisol

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    111 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    no serious acute hepatitis
    Arm Type
    Other
    Arm Title
    Serious acute hepatitis
    Arm Type
    Other
    Arm Title
    Healthy volunteers
    Arm Type
    Other
    Arm Title
    Surrenal insufficiency
    Arm Type
    Other
    Intervention Type
    Biological
    Intervention Name(s)
    Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL
    Primary Outcome Measure Information:
    Title
    Concentration of the serum total cortisol (STC) in SAH.
    Time Frame
    2 years
    Title
    Concentration of the serum free cortisol (SFC) in SAH.
    Time Frame
    2 years
    Title
    Concentration of the salivary cortisol (SalivCort) in SAH.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/21281437
    Description
    article

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    ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS

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