Cirrhotic Patients With Ascites Clinical Trial
— CIRCOPEPOfficial title:
Evaluation of Copeptin in Patients With Cirrhosis and Ascites
| NCT number | NCT03318601 |
| Other study ID # | CIRCOPEP study |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 9, 2016 |
| Est. completion date | May 9, 2019 |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | May 9, 2019 |
| Est. primary completion date | May 9, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Besançon | Besançon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Besancon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correlation between copetine and other biomarkers | Correlation will be studied with the Spearmann or Pearson' correlation coefficient | Day 0 | |
| Primary | Correlation between copetine and other biomarkers | Correlation will be studied with the Spearmann or Pearson' correlation coefficient | Day 7 | |
| Primary | Correlation between copetine and other biomarkers | Correlation will be studied with the Spearmann or Pearson' correlation coefficient | Day 15 | |
| Secondary | Performance of CRP | ROC curve | Day 0 | |
| Secondary | Performance of IL-6 | ROC curve | Day 0 | |
| Secondary | Performance of LPS | ROC curve | Day 0 | |
| Secondary | Performance of copeptine | ROC curve | Day 0 | |
| Secondary | Copetine variation | pronostic interest | Day 15 | |
| Secondary | Copetine concentrations | Compared betwenn cirhotic patient and healthy volunteers | Day 0 |