Evaluation of Copeptin in Patients With Cirrhosis and Ascites

NCT03318601 | Completed

• 1 other identifier: CIRCOPEP study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhotic Patients With Ascites

Keywords

cirrhotic; ascite; copeptin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Performance of CRP

  Day 0

• Performance of IL-6

  Day 0

• Performance of LPS

  Day 0

• Performance of copeptine

  Day 0

• Copetine variation

  Day 15

Study Arms (1)

cirrhotic patients with ascites

EXPERIMENTAL

cirrhotic patients with ascites requiring prolonged hospitalization

Procedure: Blood taking

Interventions

Blood taking PROCEDURE

Blood taking in 2 times : * J0 : 15 mL * J14 : 5 mL 20 mL in total volume

cirrhotic patients with ascites

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, 25030, France

Location

MeSH Terms

Conditions

Diabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cirrhotic patients with ascites requiring prolonged hospitalization in the Hepato-gastroenterology departments of the Besançon, Nancy and Reims hospitals.

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: May 9, 2016
• Primary Completion: December 13, 2021
• Study Completion: March 7, 2022
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)