Ascites Infection
Conditions
Keywords
Rifaximin, Norflixacin, Spontaneous bacterial peritonitis
Brief summary
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
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.
Interventions
Rifaximin was given on dose of 550 milligram every 12 hours orally for at least 3 months
Sponsors
Samar Atef Sebaweh Mohammed
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Decompensated cirrhotic patients (Child B or C, ascetic patients). 2. Adult male/female aged \>18 years old. 3. History or evidence of previous attack of SBP and currently clinically free from SBP.
Exclusion criteria
1. Recent abdominal surgery. 2. Patients with renal impairment (serum creatinine \>1.5mg/dl) at baseline. 3. Patients on renal replacement therapy (RRT) at baseline. 4. Sonographic evidence of Nephropathy other than grade I nephropathy in ascetic patients 5. intraabdominal source of infection (e.g. intra-abdominal abscesses, cholecystitis or acute pancreatitis). 6. Patients with current evidence of upper Urinary tract infection. 7. Other comorbidities affecting the patient survival e.g. significant cardiac disease, pulmonary disease, portal vein thrombosis, hepatocellular carcinoma or other malignancies, etc. 8. Sepsis. 9. Current or recent treatment with nephrotoxic drugs or contrast material injection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| secondary prophylaxis of SBP and primary prophylaxis for hepatorenal syndrome | 3 months | our study was conducted to test the efficacy of Rifaximin in prevention of recurrence of SBP and occurrence of hepatorenal syndrome |
Countries
Egypt
Outcome results
None listed