A Double Blind Randomised Controlled trial comparing Lactulose plus Rifaximin with Lactulose plus Rifaximin plus L-Ornithine L- Aspartate in treatment of Overt Hepatic Encephalopathy(Grade III-Grade IV) in patients with cirrhosis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Reversal of HE or improvement of HE by 2 grades (according to West Havens Criteria) and mental state grade after 5 days of treatment
研究概览
简要总结
This study is a randomized, double blind, parallel group, single centre trial comparing the safety and efficacy of lactulose plus rifaximin versus lactulose plus rifaximin plus L Ornithine L Aspartete in 124 patients wwith Cirrhosis with Hepatic encephalopathy Grade 3 or 4 as per West Haven’s criteria and will be conducted at single centre in India,
Theprimary outcome measure will be Reversal of HE orimprovement of HE by 2 grades (according to West Havens Criteria) and mentalstate grade after 5 days of treatment.
The Secondary Outcomes will be
1. BloodAmmonia Levels
2. SerumCytokines levels (time frame 5 days). Changes in serum cytokines measured atbaseline and after 5 days of treatment
a. Interleukin1
b. Interleukin6
c. Interleukin10
d. TNF
e. S. Endotoxins
3. Liver related death
4. Death due to other causes
5. Discontinuation due to adverseeffects
6. Rate of Recovery from HE
7. Length of hospital stay
8. Mortality (time frame 4 weeks)
9. Cause of Death
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age of patients 18-70 years.
- •Hepatic cirrhosis based on clinical, biochemical, radiological and/or histological data
- •Patients with overt acute grade 3 and 4 HE, according to the West Haven criteria, with or without precipitating factors.
排除标准
- •1.Acute on chronic liver failure 2.Hepatocellular carcinoma 3.Wilson’s disease 4.Advanced cardiac or pulmonary disease 5.Neurologic disease (including head injury and drug intoxication) CNS active drugs.
- •6.Pregnancy or breast feeding 7.Cirrhotics with h/o HE already taking L-Ornithine – L –Aspartate 8.Presence of underlying chronic renal failure (serum creatinine > 1.5mg/dl) 9.Psychiatric illness; patients who are on sedatives and antidepressants 10.Those who do not give informed consent.
结局指标
主要结局
Reversal of HE or improvement of HE by 2 grades (according to West Havens Criteria) and mental state grade after 5 days of treatment
时间窗: Reversal of HE or improvement of HE by 2 grades (according to West Havens Criteria) and mental state grade after 5 days of treatment
次要结局
- Serum Cytokines levels((IL-1,IL-6,IL-10,TNF-alpha,S. Endotoxins))
- Death due to other causes(28 days)
- Rate of Recovery from HE(5 days)
- Length of hospital stay(28 days)
- Blood Ammonia Levels(5 days)
- Discontinuation due to adverse effects(5 days)
- Liver related death(28 days)
- Mortality (time frame 4 weeks)(28 days)
- Cause of Death(28 days)