Peri-procedural antibiotics for infection prevention in transjugular intrahepatic portosystemic shunt and plug-assisted retrograde transvenous obliteration: a randomised trial

INTRODUCTION: Transjugular intrahepatic portosystemic shunt (TIPS) and plug-assisted retrograde transvenous obliteration (PARTO) are the standard of care for managing portal hypertension-related complications. However, the role of peri-procedural antibiotics in preventing infections during these interventions remains unclear because of limited evidence, and this study aimed to address this gap. METHODS: In this single-centre, double-blind, placebo-controlled, randomised trial, adult patients with portal hypertension were randomised to receive ceftriaxone (1 g twice daily until discharge) or placebo. The primary outcome was the incidence of clinically significant infection defined as fever and a quick Sequential Organ Failure Assessment (qSOFA) score ≥ 2, and secondary outcomes were hospital stay duration, in-hospital mortality and adverse events. RESULTS: Of the 70 patients, 35 received placebo and 35 received ceftriaxone (antibiotic). Twenty-one patients in the placebo arm and 22 in the antibiotic arm underwent PARTO, and the rest underwent TIPS or direct intrahepatic portocaval shunt. On Kaplan-Meier analysis, the risk of clinically significant infection (fever and qSOFA ≥ 2) was 17.1% in the placebo arm and 8.6% in the antibiotic arm (P = 0.31). Fever rates were similar (20% in the placebo arm compared with 22.9% in the antibiotic arm, P = 0.77). Hospital stay duration (4.4 ± 1.7 days in the placebo arm compared with 4.1 ± 2.2 days in the antibiotic arm, P = 0.47) and in-hospital mortality (one death per arm) were comparable. One patient in the placebo arm experienced an injection-site rash. No significant predictors of infection were identified due to the small sample size. CONCLUSION: Peri-procedural ceftriaxone did not significantly reduce infection rates in patients undergoing elective TIPS or PARTO.