Evaluation of Copeptin in Patients With Cirrhosis and Ascites (CIRCOPEP)

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 Overview

• Status: Unknown
• Conditions: Cirrhotic Patients With Ascites
• Intervention / Treatment: Procedure: Blood taking

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Delphine Weil-Verhoeven; Email: Delphine VERHOEVEN WEIL <dweil@chu-besancon.fr>

Study Locations

• France
  • Besançon, France, 25030
    • Recruiting
    • CHU de Besancon
    • Contact: Delphine Verhoeven, MD; Email: Delphine VERHOEVEN WEIL <dweil@chu-besancon.fr>

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cirrhotic patients with ascites; cirrhotic patients with ascites requiring prolonged hospitalization	Procedure: Blood taking; Blood taking in 2 times : J0 : 15 mL; J14 : 5 mL 20 mL in total volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2016
• Primary Completion (Anticipated): May 9, 2019
• Study Completion (Anticipated): May 9, 2019

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: copeptin; cirrhotic; ascite
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Pituitary Diseases; Ascites; Diabetes Insipidus
• Other Study ID Numbers: CIRCOPEP study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No