A study to compare effects of Tablet Rifaximin alone and in combination with Tablet Norfloxacin for prevention of re-occuring bacterial infection of abdominal fluid and brain function abnormality due to liver disease.
Not Applicable
Completed
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2021/09/036321
- Lead Sponsor
- Pt BD Sharma PGIMS Rohtak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 49
Inclusion Criteria
All patients with cirrhosis and ascites with hepatic encephalopathy with either gastrointestinal bleed, shock (systolic blood pressure <90 mmHg), fever or other signs of systemic inflammation like pain abdomen, diarrhea as well as in patients with worsening liver or renal function and hepatic encephalopathy shall be screened for spontaneous bacterial peritonitis by diagnostic paracentesis
Exclusion Criteria
1. Age <18 years or > 70 years
2. Pregnant females
3. Patients with chronic respiratory or kidney disease
4. Patients with diabetes mellitus or hypertension
5. Patients with hepatocellular carcinoma
6. Patients with abnormal ECG or chest radiograph
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrent episodes of spontaneous bacterial peritonitis and/or hepatic encephalopathy till next 3 months <br/ ><br>28 day and 90 day mortalityTimepoint: Recurrent episodes of spontaneous bacterial peritonitis and/or hepatic encephalopathy till next 3 months <br/ ><br>28 day and 90 day mortality
- Secondary Outcome Measures
Name Time Method umber of hospitalisation over next 3 months <br/ ><br>Episodes of upper GI bleed, acute kidney injury over next 3 months <br/ ><br>Change in model for end stage liver disease and Child Turcotte Pugh score over next 3 monthsTimepoint: Number of hospitalisation over next 3 months <br/ ><br>Episodes of upper GI bleed, acute kidney injury over next 3 months <br/ ><br>Change in model for end stage liver disease and Child Turcotte Pugh score over next 3 months