Cirrhotic Patients With Ascites
Conditions
Keywords
cirrhotic, ascite, copeptin
Brief 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.
Detailed description
The investigators wish to include prospectively 100 cirrhotic patients with ascites requiring prolonged hospitalization in the Hepato-gastroenterology departments of the Besançon, Nancy and Reims hospitals. The inclusion and follow-up periods will be six months each. At the inclusion of the patients we will evaluate the correlations between the plasma concentration of copeptin and 1 / the severity of cirrhosis (Child-Pugh and MELD scores) and serum sodium; 2 / systemic inflammation markers (CRP, leukocytes, IL-6 and lipopolysaccharides), 3 / calprotectin concentration in ascites.
Interventions
PROCEDUREBlood taking
Blood taking in 2 times : * J0 : 15 mL * J14 : 5 mL 20 mL in total volume
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
cirrhotic patients with ascites requiring prolonged hospitalization in the Hepato-gastroenterology departments of the Besançon, Nancy and Reims hospitals.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between copetine and other biomarkers | Day 0 | Correlation will be studied with the Spearmann or Pearson' correlation coefficient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of IL-6 | Day 0 | ROC curve |
| Performance of LPS | Day 0 | ROC curve |
| Performance of CRP | Day 0 | ROC curve |
| Copetine variation | Day 15 | pronostic interest |
| Copetine concentrations | Day 0 | Compared betwenn cirhotic patient and healthy volunteers |
| Performance of copeptine | Day 0 | ROC curve |
Countries
France
Outcome results
None listed