Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Rifaximin Prophylaxis Against Recurrence of Spontaneous Bacterial Peritonitis and Occurrence of Hepatorenal Syndrome in Decompensated Cirrhotic Egyptian Patients

Conditions
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Ascites Infection

Intervention / Treatment
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* Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Sepsis. Current or recent treatment with nephrotoxic drugs or contrast material injection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study design: non inferiority prospective non randomized controlled trial Study population and setting: 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. Sample size: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group or Rifaximin group<br>they received Rifaximin 550 milligram every 12 hour | Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]<br>* Rifaximin was given on dose of 550 milligram every 12 hours orally for at least 3 months<br>* Other names: xifaxan;|
| Active Comparator: control group or Norfloxacin group<br>they received Norfloxacin 400 milligram per day | Drug: Rifaximin 550 milligram Oral Tablet [XIFAXAN]<br>* Rifaximin was given on dose of 550 milligram every 12 hours orally for at least 3 months<br>* Other names: xifaxan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary prophylaxis of SBP and primary prophylaxis for hepatorenal syndrome | our study was conducted to test the efficacy of Rifaximin in prevention of recurrence of SBP and occurrence of hepatorenal syndrome | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rifaximin, Norflixacin, Spontaneous bacterial peritonitis