Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment.
研究概览
简要总结
In this study, all patients with ACLF (Acute on Chronic Liver Failure) with grade III/IV HE (Hepatic Encephalopathy) getting admitted in our institute will be enrolled after the fulfilment of inclusion/exclusion criteria and consent of the patient's attendants. Investigation of the patient (as mentioned in the proforma) will be done.
Intervention step 1:
liq Lactulose 100 mL stat followed by 30 mL/ hourly through NG/NJ route + Lactulose enema 3rd hourly - till 4 time soft stool is passed, then 30 mL through enteral route 6th hourly (If patient has no bowel sounds, only enema will be given)
Intervention step 2:
(after 24 hours of introduction of step 1, if no rapid reduction in ammonia to <70mcg/dL) Randomization to L or R arm R Arm (Addition of Rifaximin) Continuation of Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route L Arm (Lactulose only) Continuation of Lactulose therapy for further 48 hours.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and above
- •Patients with ACLF with grade III/IV HE
排除标准
- •Patients with prior decompensation
- •Grade I,II HE
- •Patients with ammonia level <70 mcg/dL
- •Patients with Septic shock
- •Pregnant lady
研究组 & 干预措施
Lactulose + Rifaximin
Continuation of Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route.
干预措施: Lactulose + Rifaximin (Drug)
Lactulose therapy
干预措施: Lactulose (Drug)
结局指标
主要结局
Reduction of ammonia level to <70 mcg/dL within 72 hours of the ammonia reduction treatment.
时间窗: 3 days
次要结局
- Liver disease related and overall mortality.(10 days)
- Reduction of ammonia level to at least 50% of the baseline value within 72 hours.(3 days)
- Duration of hepatic encephalopathy post-inclusion.(10 days)
- Improvement in hepatic encephalopathy from grade III-IV to II-I at any time within 72 hours of treatment.(3 days)
- Duration of ICU stay.(10 days)