Midodrine Versus Albumin During Large-volume Paracentesis and Its Effect on Paracentesis Induced Circulatory Disturbance in Patients With Acute on Chronic Liver Failure - A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Prevention of Paracentesis induced circulatory disturbance
研究概览
简要总结
Paracentesis-induced circulatory disturbance (PICD) is a very common cause of mortality and morbidity in patients undergoing large-volume paracentesis. Albumin is commonly used in decompensated cirrhosis during large-volume paracentesis. However, it may not be cost-effective and has side effects like volume overload and transfusion reactions.
Therefore the investigator proposed to use midodrine which is a drug that increases the mean arterial pressure. The investigators hypothesized that midodrine may be effective in preventing PICD in acute on chronic liver failure patients requiring modest paracentesis. This has already been found to be effective in initial studies in decompensated cirrhosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Consecutive patients above 18 years of age who fulfilled Asia Pacific Association of study of liver disease (APASL) criteria for ACLF and required paracentesis for moderate to tense ascites were included in the study.
- •Acute on Chronic Liver Failure (ACLF) was defined as an acute hepatic insult manifesting as jaundice (Serum bilirubin ≥ 5 mg/dL (85 micromole/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity < 40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis and is associated with a high 28-day mortality -
排除标准
- •Patients with acute kidney injury defined as serum creatine of > 0.3 mg/dl above the baseline
- •Severe cardiopulmonary disease
- •History of urinary retention
- •Pheochromocytoma
- •Thyrotoxicosis
- •Persistent and excessive supine hypertension define by systolic blood pressure > 150 mm Hg
- •Pregnant patients
- •Unable to give informed consent were excluded from the study -
研究组 & 干预措施
Arm receiving 20% Human Albumin
20% Human albumin given intravenously over 4 hours
干预措施: Human Albumin 20% (Drug)
Arm receiving Midodrine
Tablet Midodrine 2.5 mg - 3 tablets thrice daily orally starting just before paracentesis
干预措施: Midodrine Hydrochloride (Drug)
结局指标
主要结局
Prevention of Paracentesis induced circulatory disturbance
时间窗: Day 6
Measure the value of plasma renin activity on sixth day after paracentesis
次要结局
- Cost effectiveness of Midodrine versus Albumin(Day 6)
- Hepatic Encephalopathy as measured by West-Haven criteria(Day 6)
- Renal outcome post paracentesis(Day 6)
研究者
Dr Mithun Sharma
Director Hepatology and Regenerative Medicine
Asian Institute of Gastroenterology, India