A study to see the effect of lactulose plus rifaximin versus lactulose plus rifaximin plus L Ornithine L Aspartate in treatment of brain dysfunction associated with chronic liver disease
- Conditions
- Health Condition 1: K740- Hepatic fibrosis
- Registration Number
- CTRI/2019/05/018966
- Lead Sponsor
- Department of Gastroenterology G B Pant Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Age of patients 18-70 years.
2. Hepatic cirrhosis based on clinical, biochemical, radiological and/or histological data
3. Patients with overt acute grade 3 and 4 HE, according to the West Haven criteria, with or without precipitating factors
1.Acute on chronic liver failure
2.Hepatocellular carcinoma
3.Wilsonâ??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 â?? L â??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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reversal of HE or improvement of HE by 2 grades (according to West Havens Criteria) and mental state grade after 5 days of treatmentTimepoint: Reversal of HE or improvement of HE by 2 grades (according to West Havens Criteria) and mental state grade after 5 days of treatment
- Secondary Outcome Measures
Name Time Method Blood Ammonia LevelsTimepoint: 5 days;Cause of DeathTimepoint: 28 days;Death due to other causesTimepoint: 28 days;Discontinuation due to adverse effectsTimepoint: 5 days;Length of hospital stayTimepoint: 28 days;Liver related deathTimepoint: 28 days;Mortality (time frame 4 weeks)Timepoint: 28 days;Rate of Recovery from HETimepoint: 5 days;Serum Cytokines levels <br/ ><br>(IL-1,IL-6,IL-10,TNF-alpha,S. Endotoxins)Timepoint: 5 days