ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS (NCT02859584) | Clinical Trial Compass
CompletedNot Applicable
ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS
111 participantsStarted 2011-08
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Refusa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of the serum total cortisol (STC) in SAH.
Timeframe: 2 years
2
Concentration of the serum free cortisol (SFC) in SAH.
Timeframe: 2 years
3
Concentration of the salivary cortisol (SalivCort) in SAH.
Timeframe: 2 years
Trial details
NCT IDNCT02859584
SponsorCentre Hospitalier Universitaire de Besancon