Clinical trial NCT03318601: Evaluation of Copeptin in Patients With Cirrhosis and Ascites
Official title: Evaluation of Copeptin in Patients With Cirrhosis and Ascites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhotic Patients With Ascites
Keywords: cirrhotic
ascite
copeptin
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cirrhotic patients with ascites requiring prolonged hospitalization in the Hepato-gastroenterology departments of the Besançon, Nancy and Reims hospitals.
Primary purpose: OTHER

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. "

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

Primary outcomes:
measure: Correlation between copetine and other biomarkers
timeFrame: Day 0
measure: Correlation between copetine and other biomarkers
timeFrame: Day 7
measure: Correlation between copetine and other biomarkers
timeFrame: Day 15
Secondary outcomes:
measure: Performance of CRP
timeFrame: Day 0
measure: Performance of IL-6
timeFrame: Day 0
measure: Performance of LPS
timeFrame: Day 0
measure: Performance of copeptine
timeFrame: Day 0
measure: Copetine variation
timeFrame: Day 15
measure: Copetine concentrations
timeFrame: Day 0
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References: