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N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis

RecruitingPhase 1, Phase 2Ages 18 Years - 65 YearsAllTanta University
NCT07803952 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Spontaneous bacterial peritonitis (SBP) is one of the most serious infectious complications of liver cirrhosis and ascites. It affects approximately 10-30% of hospitalized patients with decompensated cirrhosis and carries an in-hospital mortality of 20-40% despite appropriate antimicrobial therapy. SBP results from bacterial translocation across the intestinal mucosa together with cirrhosis-associated immune dysfunction, leading to impaired bacterial clearance and exaggerated systemic inflammation. Current international guidelines recommend immediate empirical antibiotic therapy together with intravenous human albumin to reduce the incidence of acute kidney injury (AKI), hepatorenal syndrome, and mortality. Although this strategy has substantially improved outcomes, treatment failure, persistent infection, renal dysfunction, acute-on-chronic liver failure (ACLF), and early mortality rem

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📋 Eligibility rules (as published)
Inclusion Criteria: Adult patients (≥18 years) with liver cirrhosis, confirmed by clinical, radiological, or histopathological findings, who are newly diagnosed with SBP based on an ascitic fluid polymorphonuclear (PMN) leukocyte count ≥250 cells/mm³ according to the American Association for the Study of Liver Diseases (AASLD) criteria (2). Eligible participants were required to have undergone diagnostic paracentesis for ascitic fluid analysis and to provide informed consent prior to enrollment. Exclusion Criteria * Secondary bacterial or fungal peritonitis. * Recent abdominal surgery or requiring immediate surgical intervention. * Known hypersensitivity to NAC. * Pregnancy or lactation. * Septic shock, established HRS-AKI requiring rescue therapy, or renal replacement therapy at enrollment. * Advanced malignancy or terminal illness. * Previous NAC administration during the current SBP episode. * Inability to receive oral study medication. * Participation in another interventional trial that may affect study outcomes.
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What it tests

  • Placebo
  • NAC
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Where

1 site
Tanta University Hospital
Tanta, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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