Evaluation of Copeptin in Patients With Cirrhosis and Ascites

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 9, 2019

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. "

Interventions

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

Arms, Groups and Cohorts

  • Experimental: cirrhotic patients with ascites
    • cirrhotic patients with ascites requiring prolonged hospitalization

Clinical Trial Outcome Measures

Primary Measures

  • Correlation between copetine and other biomarkers
    • Time Frame: Day 0
    • Correlation will be studied with the Spearmann or Pearson’ correlation coefficient
  • Correlation between copetine and other biomarkers
    • Time Frame: Day 7
    • Correlation will be studied with the Spearmann or Pearson’ correlation coefficient
  • Correlation between copetine and other biomarkers
    • Time Frame: Day 15
    • Correlation will be studied with the Spearmann or Pearson’ correlation coefficient

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Besancon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Delphine Weil-Verhoeven, Delphine VERHOEVEN WEIL <dweil@chu-besancon.fr>

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.