Evaluation of Copeptin in Patients With Cirrhosis and Ascites

Not Applicable

Completed

• Conditions: Cirrhotic Patients With Ascites
• Interventions: Procedure: Blood taking

• Registration Number: NCT03318601
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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. "

Study Timeline

• Study Start: 2016-05-09
• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-24
• Primary Completion: 2021-12-13
• Study Completion: 2022-03-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cirrhotic patients with ascites	Blood taking	cirrhotic patients with ascites requiring prolonged hospitalization

Primary Outcome Measures

Name	Time	Method
Correlation between copetine and other biomarkers	Day 15	Correlation will be studied with the Spearmann or Pearson' correlation coefficient

Secondary Outcome Measures

Name	Time	Method
Performance of CRP	Day 0	ROC curve
Performance of IL-6	Day 0	ROC curve
Performance of LPS	Day 0	ROC curve
Performance of copeptine	Day 0	ROC curve
Copetine variation	Day 15	pronostic interest
Copetine concentrations	Day 0	Compared betwenn cirhotic patient and healthy volunteers

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France