TO COMPARE THE EFFICACY OF N -ACETYLCYSTEINE AND STANDARD THERAPY VERSUS STANDARD THERAPY IN THE PREVENTION OF ISCHEMIC HEPATITIS AND SURVIVAL POST UPPER GI BLEED
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To study the efficacy of NAC (N -ACETYLCYSTEINE) in preventing ischemic hepatitis in cirrhotics with upper Gastrointestinal bleed.
研究概览
简要总结
Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences) emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care Unit) in view of upper GI bleed randomized to two groups
GROUP A : 110 Patients will receive standard care + NAC infusion for 72 hours
GROUP B : 110 Patients will receive standard care only
NAC will be given at following rate :
Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then continuous infusion of 6.25 mg/kg for the remaining 67 hrs
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
- •Age > 18 and < 75
- •Cirrhotics with UGIE (Upper Gastrointestinal Endoscopy ) within last 24 hours.
排除标准
- •Non cirrhotic
- •Hepatocellular carcinoma
- •Advanced cardiopulmonary disease
- •Pregnancy
- •Extrahepatic malignancy
- •Patient on anticoagulation therapy
研究组 & 干预措施
Standard Care + NAC (N-ACETYLCYSTEINE) infusion
干预措施: Standard Care + NAC (N -ACETYLCYSTEINE) (Drug)
Standard Care + NAC (N-ACETYLCYSTEINE) infusion
干预措施: Standard Care (in control arm) (Drug)
Standard Care
干预措施: Standard Care (in control arm) (Drug)
结局指标
主要结局
To study the efficacy of NAC (N -ACETYLCYSTEINE) in preventing ischemic hepatitis in cirrhotics with upper Gastrointestinal bleed.
时间窗: Day 5
次要结局
- To study effect of NAC (N -ACETYLCYSTEINE) infusion on 5 day survival post bleed.(6 weeks)
- To study incidence of complication like AKI (Acute Kidney Injury), HE(Hepatic Encepahlopathy) and SBP(Spontaneous Bacterial Peritonitis).(day 5)