Clinical Trials Directory

Trials / Completed

CompletedNCT03318601

Evaluation of Copeptin in Patients With Cirrhosis and Ascites

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Centre Hospitalier Universitaire de Besancon · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREBlood takingBlood taking in 2 times : * J0 : 15 mL * J14 : 5 mL 20 mL in total volume

Timeline

Start date
2016-05-09
Primary completion
2021-12-13
Completion
2022-03-07
First posted
2017-10-24
Last updated
2025-01-16

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03318601. Inclusion in this directory is not an endorsement.