Ignite Creation Date:
2024-05-06 @ 10:38 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03318601
Status:
UNKNOWN
Last Update Posted:
2018-07-18
First Post:
2017-10-19
Brief Title:
Evaluation of Copeptin in Patients With Cirrhosis and Ascites
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
Evaluation of Copeptin in Patients With Cirrhosis and Ascites
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIRCOPEP
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None