Evaluation of Copeptin in Patients With Cirrhosis and Ascites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Correlation between copetine and other biomarkers
研究概览
简要总结
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.
详细描述
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. "
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
cirrhotic patients with ascites
cirrhotic patients with ascites requiring prolonged hospitalization
干预措施: Blood taking (Procedure)
结局指标
主要结局
Correlation between copetine and other biomarkers
时间窗: Day 15
Correlation will be studied with the Spearmann or Pearson' correlation coefficient
次要结局
- Performance of CRP(Day 0)
- Performance of IL-6(Day 0)
- Performance of LPS(Day 0)
- Performance of copeptine(Day 0)
- Copetine variation(Day 15)
- Copetine concentrations(Day 0)