Evaluation of Copeptin in Patients With Cirrhosis and Ascites

Study Overview
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Brief Summary
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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
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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. 

Official Title
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Evaluation of Copeptin in Patients With Cirrhosis and Ascites

Conditions
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Cirrhotic Patients With Ascites

Intervention / Treatment
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* Procedure: Blood taking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: cirrhotic patients with ascites requiring prolonged hospitalization in the Hepato-gastroenterology departments of the Besançon, Nancy and Reims hospitals.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cirrhotic patients with ascites<br>cirrhotic patients with ascites requiring prolonged hospitalization | Procedure: Blood taking<br>* Blood taking in 2 times : J0 : 15 mL J14 : 5 mL 20 mL in total volume<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between copetine and other biomarkers | Correlation will be studied with the Spearmann or Pearson' correlation coefficient | Day 0 | 
| Correlation between copetine and other biomarkers | Correlation will be studied with the Spearmann or Pearson' correlation coefficient | Day 7 | 
| Correlation between copetine and other biomarkers | Correlation will be studied with the Spearmann or Pearson' correlation coefficient | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of CRP | ROC curve | Day 0 | 
| Performance of IL-6 | ROC curve | Day 0 | 
| Performance of LPS | ROC curve | Day 0 | 
| Performance of copeptine | ROC curve | Day 0 | 
| Copetine variation | pronostic interest | Day 15 | 
| Copetine concentrations | Compared betwenn cirhotic patient and healthy volunteers | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhotic, ascite, copeptin