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

Primary Purpose

Cirrhotic Patients With Ascites

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood taking
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cirrhotic Patients With Ascites focused on measuring cirrhotic, ascite, copeptin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de BesançonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cirrhotic patients with ascites

Arm Description

cirrhotic patients with ascites requiring prolonged hospitalization

Outcomes

Primary Outcome Measures

Correlation between copetine and other biomarkers
Correlation will be studied with the Spearmann or Pearson' correlation coefficient
Correlation between copetine and other biomarkers
Correlation will be studied with the Spearmann or Pearson' correlation coefficient
Correlation between copetine and other biomarkers
Correlation will be studied with the Spearmann or Pearson' correlation coefficient

Secondary Outcome Measures

Performance of CRP
ROC curve
Performance of IL-6
ROC curve
Performance of LPS
ROC curve
Performance of copeptine
ROC curve
Copetine variation
pronostic interest
Copetine concentrations
Compared betwenn cirhotic patient and healthy volunteers

Full Information

First Posted
October 19, 2017
Last Updated
July 17, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT03318601
Brief Title
Evaluation of Copeptin in Patients With Cirrhosis and Ascites
Acronym
CIRCOPEP
Official Title
Evaluation of Copeptin in Patients With Cirrhosis and Ascites
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 9, 2016 (Actual)
Primary Completion Date
May 9, 2019 (Anticipated)
Study Completion Date
May 9, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. "

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhotic Patients With Ascites
Keywords
cirrhotic, ascite, copeptin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
cirrhotic patients with ascites requiring prolonged hospitalization in the Hepato-gastroenterology departments of the Besançon, Nancy and Reims hospitals.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cirrhotic patients with ascites
Arm Type
Experimental
Arm Description
cirrhotic patients with ascites requiring prolonged hospitalization
Intervention Type
Procedure
Intervention Name(s)
Blood taking
Intervention Description
Blood taking in 2 times : J0 : 15 mL J14 : 5 mL 20 mL in total volume
Primary Outcome Measure Information:
Title
Correlation between copetine and other biomarkers
Description
Correlation will be studied with the Spearmann or Pearson' correlation coefficient
Time Frame
Day 0
Title
Correlation between copetine and other biomarkers
Description
Correlation will be studied with the Spearmann or Pearson' correlation coefficient
Time Frame
Day 7
Title
Correlation between copetine and other biomarkers
Description
Correlation will be studied with the Spearmann or Pearson' correlation coefficient
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Performance of CRP
Description
ROC curve
Time Frame
Day 0
Title
Performance of IL-6
Description
ROC curve
Time Frame
Day 0
Title
Performance of LPS
Description
ROC curve
Time Frame
Day 0
Title
Performance of copeptine
Description
ROC curve
Time Frame
Day 0
Title
Copetine variation
Description
pronostic interest
Time Frame
Day 15
Title
Copetine concentrations
Description
Compared betwenn cirhotic patient and healthy volunteers
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine Weil-Verhoeven
Email
Delphine VERHOEVEN WEIL <dweil@chu-besancon.fr>
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine Verhoeven, MD
Email
Delphine VERHOEVEN WEIL <dweil@chu-besancon.fr>

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Copeptin in Patients With Cirrhosis and Ascites

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