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Completed

NCT Number: NCT03318601

Evaluation of Copeptin in Patients With Cirrhosis and Ascites

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon

Besançon, 25030, France

About this study

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. "

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood taking

Procedure

Blood taking in 2 times :

  • J0 : 15 mL
  • J14 : 5 mL 20 mL in total volume

Primary outcomes

  1. Correlation between copetine and other biomarkers

    Time frame: Day 0

    Correlation will be studied with the Spearmann or Pearson' correlation coefficient

  2. Correlation between copetine and other biomarkers

    Time frame: Day 7

    Correlation will be studied with the Spearmann or Pearson' correlation coefficient

  3. Correlation between copetine and other biomarkers

    Time frame: Day 15

    Correlation will be studied with the Spearmann or Pearson' correlation coefficient

Secondary outcomes

  1. Performance of CRP

    Time frame: Day 0

    ROC curve

  2. Performance of IL-6

    Time frame: Day 0

    ROC curve

  3. Performance of LPS

    Time frame: Day 0

    ROC curve

  4. Performance of copeptine

    Time frame: Day 0

    ROC curve

  5. Copetine variation

    Time frame: Day 15

    pronostic interest

  6. Copetine concentrations

    Time frame: Day 0

    Compared betwenn cirhotic patient and healthy volunteers

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: CIRCOPEP

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Oct 24, 2017
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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