Evaluation of Copeptin in Patients With Cirrhosis and Ascites

NCT ID: NCT03318601

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-09
• Study Completion Date: 2022-03-07

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. "

Conditions

Cirrhotic Patients With Ascites

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

cirrhotic patients with ascites

cirrhotic patients with ascites requiring prolonged hospitalization

Group Type: EXPERIMENTAL

Blood taking

Intervention Type: PROCEDURE

Blood taking in 2 times :

• J0 : 15 mL
• J14 : 5 mL 20 mL in total volume

Interventions

Blood taking

Blood taking in 2 times :

• J0 : 15 mL
• J14 : 5 mL 20 mL in total volume

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Besançon

Besançon, , France

Countries

France

Other Identifiers

CIRCOPEP study

Identifier Type: -

Identifier Source: org_study_id