Evaluation of Copeptin in Patients With Cirrhosis and Ascites (NCT03318601) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Copeptin in Patients With Cirrhosis and Ascites
France100 participantsStarted 2016-05-09
Plain-language summary
Copeptin is a glycopeptide released by the post-pituitary gland. In case of decrease in blood volume or blood pressure, it is secreted in the serum in an equimolar quantity to arginine vasopressin (AVP) . Unlike AVP, copeptin is readily assayable in serum and its prognostic value has been recently observed during cirrhosis. However, the pathophysiological relationships between serum copeptin concentrations and indirect markers of inflammation are unknown.
The main objective of this multicenter pilot study is to study the relationship between serum copeptin and markers of inflammatory stress in cirrhotic patients with ascites. It is indeed in this population with high-risk of complications that most need biomarkers of events (like death) are needed. The main secondary objective is to evaluate the prognostic interest at 6 months of the variation of copeptin between day 0- day15.
Who can participate
Age range
18 Years – 80 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:
* Man or woman
* Age between 18 and 80 years
* Acute decompensation of cirrhosis with occurrence of ascites
* Hospitalisationfor a complication of cirrhosis (first occurrence of ascites or recurrent ascites requiring hospitalization, gastrointestinal bleeding, hepatic encephalopathy, etc..)
* Patients participating to Ca-DRISLA study
* Information and Consent form signed
Exclusion Criteria:
* Pregnant or breastfeeding woman
* Age minor to 18 years
* Age major to 80 years
* Adult under protection law
* outpatients hospitalized for paracentesis
* ascites not related to portal hypertension (pancreatic ascites, peritoneal carcinosis…) Patients with hepatocellular carcinoma could be included
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
Correlation between copetine and other biomarkers
Timeframe: Day 0
2
Correlation between copetine and other biomarkers
Timeframe: Day 7
3
Correlation between copetine and other biomarkers
Timeframe: Day 15
Trial details
NCT IDNCT03318601
SponsorCentre Hospitalier Universitaire de Besancon