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Trial record 5 of 29 for:    Recruiting, Not yet recruiting, Available Studies | "Diabetes Insipidus"

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

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ClinicalTrials.gov Identifier: NCT03318601
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.


Condition or disease Intervention/treatment Phase
Cirrhotic Patients With Ascites Procedure: Blood taking Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Evaluation of Copeptin in Patients With Cirrhosis and Ascites
Actual Study Start Date : May 9, 2016
Estimated Primary Completion Date : May 9, 2019
Estimated Study Completion Date : May 9, 2019


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318601


Contacts
Contact: Delphine Weil-Verhoeven Delphine VERHOEVEN WEIL <dweil@chu-besancon.fr>

Locations
France
CHU de Besançon Recruiting
Besançon, France, 25030
Contact: Delphine Verhoeven, MD       Delphine VERHOEVEN WEIL <dweil@chu-besancon.fr>   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03318601     History of Changes
Other Study ID Numbers: CIRCOPEP study
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
cirrhotic
ascite
copeptin

Additional relevant MeSH terms:
Diabetes Insipidus
Ascites
Pathologic Processes
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs