CTRI/2023/01/048824已完成未知
RIFAXIMIN WITH STANDARD MEDICAL TREATMENT VERSUS STANDARD MEDICAL TREATMENT ALONE IN PATIENTS WITH FRAILTY IN DECOMPENSATED CIRRHOSIS - AN OPEN LABEL RANDOMISED TRIA
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PGIMER
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age 18-75 years
- •2. Patient of decompensated cirrhosis of any aetiology
- •3. Presence of frailty
排除标准
- •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
研究者
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