Clinical, Biochemical and Haemodynamic Effects of Large-volume Paracentesis (LVP) in Inflammatory Situations
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change over time of stroke-volume (milliliter) before, under and after paracentesis
研究概览
简要总结
This observational study evaluates the clinical, biochemical and haemodynamic effects of large-volume paracentesis (LVP) in 50 patients with and without signs of inflammation
详细描述
Ascites is one of the common complications in advanced liver cirrhosis. Large-volume paracentesis (LVP) is a widely used symptomatic intervention to remove large amounts of peritoneal fluid. Despite a low rate of interventional-associated complications like fistula or non life-threatening bleeding LVP induces an impairment of circulatory function. The hypothesis is that haemodynamic changes can be detected by non-invasive monitoring and that these haemodynamic changes could be associated to postinterventional organ dysfunction or complications. Additionally the investigators hypothesize that paracentesis-induced circulatory dysfunction could also be associated to present clinical and laboratory signs of inflammation or infection and could influenced by increased viable and non-viable bacterial translocation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male Patients between 18-70 years with liver cirrhosis and ascites
- •Indication for paracentesis
排除标准
- •Infectious disease in the last 4 weeks
- •Active alcohol-consumption or missing data of alcohol use
- •Missing inform consent
- •Missing speech comprehension
- •Neurological or psychiatric disease that compromise consenting
- •Hepatic encephalopathy stage III (West-Haven criteria)
- •Heart failure NYHA IV
- •Renal insufficiency or hepatorenal syndrome
- •Atrial fibrillation
- •Pacemaker
结局指标
主要结局
Change over time of stroke-volume (milliliter) before, under and after paracentesis
时间窗: 10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis
Baseline Monitoring 10 minutes before paracentesis, under paracentesis, 12 hours, 24 hours and 48 hours after paracentesis
Change over time of arterial pressure (millimeter of mercury) before, under and after paracentesis
时间窗: 10 minutes prior to start of paracentesis and 30 minutes, 60 minutes, 12 hours, 24 hours, and 48 hours after start of paracentesis
Baseline Monitoring 10 minutes before paracentesis, under paracentesis, 12 hours, 24 hours and 48 hours after paracentesis
次要结局
- Incidence of adverse effects(Over the full time of paracentesis, 12 hours and 48 hours and up to 2 weeks after paracentesis)
研究者
Dr. med. Donata Grajecki
Dr. med.
Charite University, Berlin, Germany