Efficacy of Albumin Plus Midodrine v/s Albumin Alone in Reducing Incidence of Paracentesis Induced Circulatory Dysfunctions in ACLF Patients-A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of PICD (Paracentesis Induced Circulatory Dysfunction)
研究概览
简要总结
The patients with ACLF having Ascites who require ascitic tapping will undergone ascitic tapeither under albumin cover alone or with midodrine. The patient will be monitored for complication and changes of PICD. Study analysis will be done with primary objective being reduction in incidence of PICD.
详细描述
OBJECTIVE:
Primary objective: Incidence of Paracentesis induced circulatory dysfunction in patients undergoing modest volume paracentesis (MVP) (>3 and <5 litres) with midodrine plus 25% albumin v/s 25% albumin infusion alone at day 7
Secondary objective:
- Change in systolic, diastolic and mean BP at day 3 and 6
- Increase in plasma renin activity at day 6
- Incidence of Hyponatremia, HE and AKI at day 3 and 6
- Predictors of Paracentesis induced circulatory dysfunction
- Predictors of 28 day survival.
Methodology :
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
- Single (Participant)
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
- •ACLF patients (as per APASL definition) with grade II/III ascites
排除标准
- •Age < 18 or >75 years
- •Hepatocellular carcinoma
- •Extrahepatic portal vein obstruction
- •Non cirrhotic ascites
- •Serum creatinine >1.5mg/dl
- •Refractory septic shock
- •Beta blockersPortal vein thrombosis
- •Grade 3-4 HE
- •Pregnancy or Lactation
- •Active variceal bleed
- •Respiratory, cardiac, renal failure
- •Uncontrolled hypertension
- •Severe coagulopathy
- •Refusal to participate
研究组 & 干预措施
Albumin with placebo
Group A will be given albumin 8g/l of ascitic tap along with placebo for 7 days. Standard albumin therapy will continue (40gm/week)
干预措施: Albumin (Biological)
Albumin with placebo
Group A will be given albumin 8g/l of ascitic tap along with placebo for 7 days. Standard albumin therapy will continue (40gm/week)
干预措施: Placebo (Other)
Albumin with Midodrine
GROUP B will be given midodrine 7.5 mg to 10 mg tds (keeping the target MAP above 70 mmhg)for 7 days plus albumin same as in other group.
干预措施: Albumin (Biological)
Albumin with Midodrine
GROUP B will be given midodrine 7.5 mg to 10 mg tds (keeping the target MAP above 70 mmhg)for 7 days plus albumin same as in other group.
干预措施: Midodrine Oral Tablet (Drug)
结局指标
主要结局
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction)
时间窗: Day 6
次要结局
- Changes in Mean Arterial Pressure (MAP) post paracentesis.(Day 6)
- Incidence of Hepatic Encephalopathy in both groups(Day 6)
- Incidence of Acute Kidney Injury in both groups(Day 6)
- Incidence of Hyponatremia in both groups(Day 6)
- Changes in Heart Rate post paracentesis.(Day 6)
- Change in plasma renin activity in both groups(Day 6)