Continuous Passive Paracentesis Versus Large Volume Paracentesis in the Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome in the Critically Ill Cirrhotic Patient With Ascites
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Renal function - creatinine clearance
研究概览
简要总结
Liver cirrhosis patients in Intensive Care present intra-abdominal hypertension and this is an independent risk factor for increased organ disfunction and mortality.
Patients will be randomized into intermittent or continuous passive paracentesis and the clinical results of these two strategies for preventing and treating intra-abdominal hypertension will compared.
详细描述
Intra-abdominal hypertension is an independent risk factors for increased mortality in Intensive Care patients and is highly prevalent in the critically ill cirrhotic patient. This study compares two strategies in minimizing intra-abdominal pressure and optimizing abdominal perfusion pressure in the prevention and treatment of intra-abdominal hypertension associated morbidity and mortality. Critically ill cirrhotic patients will be allocated into a standard-of-care large-volume paracentesis group (control) and a continuous passive paracentesis (intervention) group using randomization. Results will assess renal function and multi-organ function using standard clinical scales and vital outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •liver cirrhosis diagnosis with ascites
- •ICU admission for medical reason
排除标准
- •prior liver transplant
- •haemorrhagic ascites
- •extreme severity: CLIF-SOFA number of organ failures 5 or more
- •less than 24 hours of ICU stay
- •Any of the following conditions at 24 hours of ICU stay:
- •i. Hemorrhagic shock with active uncontrolled bleeding ii. Refractory shock (MAP<60mmHg) with multiple vasopressors iii. Predictably short ICU stay (<72 hours) iv. Therapeutic futility determined by the medical staff
结局指标
主要结局
Renal function - creatinine clearance
时间窗: intensive care stay up to 7 days
estimated and measured creatinine clearance (mL/min)
Renal function - urine output
时间窗: intensive care stay up to 7 days
measured urine output (mL/min)
Renal function - renal replacement therapy
时间窗: intensive care stay up to 7 days
number of renal replacement therapy days
Multi-organ disfunction
时间窗: intensive care stay up to 7 days
Clinical multi-organ disfunction as assessed by severity scores: Sequencial Organ Failure Assessement (SOFA) and Chronic Liver Failure-SOFA (CLIF-SOFA). Both scores range \[0-24\] and higher scores reflect more severe organ dysfunctions and worse outcomes.
次要结局
- 30 days Mortality rate(from admission into the ICU up to 30 days onwards)
- in hospital Mortality rate(from admission into the ICU up to 60 days onwards)
- ICU Mortality rate(from admission into the ICU up to 30 days onwards)
- Emergent liver transplant rate(from admission into the ICU up to 28 days onwards)