Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Rifaximin: Patients will be randomised by computer generated randomisation and patients which will come in the intervention arm will receive Rifaximin 550 mg twice a day with standard m
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years 2. Patient of decompensated cirrhosis of any aetiology 3. Presence of frailty
Exclusion criteria
Exclusion criteria: 1. Patients with CTP score more than 10 2. Patients with history of hepatic encephalopathy 3. Patient with acute on chronic liver failure (ACLF) 4. Obese patient (BMI;25kg/m2) 5. Patients with active malignancy, hepatocellular carcinoma and end- stage renal disease 6. Patients having prior study enrolment or enrolment in another conflicting study. 7. Patients, who are not willing to participate in the study. 8. Patients who are participating in other clinical trials within past 3 months. 9. Patients who has an active evidence of infection 10. Patients who had acute organic brain disease in the past 6 months 11. Patients who has severe hemodynamic instability, serious heart disease, severe bradycardia or tachycardia at rest 12. Patients having renal failure (creatinine clearance rate =60 mL/min/1.73 m2). 13. Patients with severe cognitive impairment (Mini-Mental State Examination =17), overt hepatic encephalopathy or patients who had physical disability. 14. Patients with HIV 15. Pregnancy 16. Post liver transplant patients 17. Exposure to rifaximin in the previous 12 weeks 18. Patients receiving concomitant secondary prophylaxis for SBP 19. Known hypersensitivity to Rifaximin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To see the effect of rifaximin on frailty in decompensated cirrhosis as measured by Liver Frailty Index (LFI). Timepoint: Patients will be enrolled in an expected period of 18 months Liver Frailty Index (LFI) will be calculated at baseline at 3 month and at 6 month of follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| •To see change in prognostic scores (CTP/ MELD/ MELD Na) at 6 month •To see change in levels of inflammatory markers and ammonia at 6 month •To see change in sarcopenia (skeletal muscle at L3 vertebral level on CT) at 6 month •Survival & hospitalisation •Change in quality of life at 6 month •Adverse events as per World Health Organization (WHO grading) Timepoint: Patients will be enrolled in an expected period of 18 months Patients will be followed up for their final outcomes for next 6 months with measurements of various outcomes at baseline and at 6 month | — |
Countries
India
Contacts
Public ContactSweta Rose
PGIMER
Outcome results
None listed