Rifaximin Prophylaxis Against Recurrence of Spontaneous Bacterial Peritonitis and Occurrence of Hepatorenal Syndrome in Decompensated Cirrhotic Egyptian Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- secondary prophylaxis of SBP and primary prophylaxis for hepatorenal syndrome
研究概览
简要总结
Norfloxacin is the most commonly used drug for the prophylaxis against spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis. Rifaximin, another broad spectrum antibiotic with only trivial absorption from the gut, is used for the treatment of traveler's diarrhea and prevention of hepatic encephalopathy.
详细描述
Prophylaxis against spontaneous bacterial peritonitis (SBP) in cirrhotic patients recovered from an episode of SBP using Norfloxacin 400 mg/day is currently established standard of care. Recently we are facing the growing challenge of standard SBP prophylaxis lacking efficacy as extended spectrum beta-lactamases and fluoro-quinolone resistant bacteria in isolates of patients on Norfloxacin.
Prophylaxis against Hepatorenal Syndrome in decompensated liver cirrhosis is limited to IV administration of Albumin in patients who develop SBP and the prevention of SBP using Norfloxacin.
this study aims to investigate the effectiveness of Rifaximin in decompensated cirrhotic patients against SBP as a secondary prophylaxis measure and Hepatorenal Syndrome.
our study was non inferiority prospective non randomized controlled trial The study enrolled patients with chronic liver disease and ascites who were monitored at outpatient clinics or who were admitted to Ain Shams University hospitals.104 patients with decompensated liver cirrhosis were enrolled in the study, The Control Group (n=52), to receive standard of care treatment & Norfloxacin prophylaxis for the decompensated liver disease and a second Treatment Group (n=52) who will receive Rifaximin prophylaxis in addition to the original management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Decompensated cirrhotic patients (Child B or C, ascetic patients).
- •Adult male/female aged >18 years old.
- •History or evidence of previous attack of SBP and currently clinically free from SBP.
排除标准
- •Recent abdominal surgery.
- •Patients with renal impairment (serum creatinine >1.5mg/dl) at baseline.
- •Patients on renal replacement therapy (RRT) at baseline.
- •Sonographic evidence of Nephropathy other than grade I nephropathy in ascetic patients
- •intraabdominal source of infection (e.g. intra-abdominal abscesses, cholecystitis or acute pancreatitis).
- •Patients with current evidence of upper Urinary tract infection.
- •Other comorbidities affecting the patient survival e.g. significant cardiac disease, pulmonary disease, portal vein thrombosis, hepatocellular carcinoma or other malignancies, etc.
- •Current or recent treatment with nephrotoxic drugs or contrast material injection.
研究组 & 干预措施
treatment group or Rifaximin group
they received Rifaximin 550 milligram every 12 hour
干预措施: Rifaximin 550 milligram Oral Tablet [XIFAXAN] (Drug)
control group or Norfloxacin group
they received Norfloxacin 400 milligram per day
干预措施: Rifaximin 550 milligram Oral Tablet [XIFAXAN] (Drug)
结局指标
主要结局
secondary prophylaxis of SBP and primary prophylaxis for hepatorenal syndrome
时间窗: 3 months
our study was conducted to test the efficacy of Rifaximin in prevention of recurrence of SBP and occurrence of hepatorenal syndrome
次要结局
未报告次要终点
研究者
Samar Atef Sebaweh Mohammed
assistant lecturer
Ain Shams University