A pilot randomised, open label controlled trial comparing safety and efficacy of pleural irrigation with normal saline versus intrapleural tissue plasminogen activator and DNase (fibrinolytic therapy) in pleural infection

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Management of pleural infection included adjunctive intrapleural fibrinolytic therapy (IPFT) using alteplase and Deoxyribonuclease (DNase) and saline irrigation. This study compared the safety and efficacy of IPFT versus saline irrigation. This open-label, randomized trial allocated patients to receive IPFT (5 mg alteplase with 5 mg DNase) or saline irrigation (250 milliliters three times daily for 3 days). The primary outcome was a safety comparison between the two arms. Secondary outcomes included pleural fluid drainage, radiographic clearance, inflammatory markers resolution, length of hospitalization, treatment success, and mortality at 30 days. Forty subjects were randomized. Safety outcomes were similar, with no adverse events observed. Two patients in the saline arm failed therapy at day 7 and required crossover to IPFT. Both groups demonstrated substantial pleural drainage and biochemical improvement, with greater but non-significant radiological clearance in the IPFT group. At day 7, treatment success was 100% in the IPFT group [intention to treat (ITT) 20/20; per-protocol (PP) 20/20] and 90% in the saline group (ITT 18/20; PP 18/20). By day 30, success was 100% in both groups (IPFT, ITT 20/20; PP 19/19; saline, ITT 20/20; PP 18/18). Mortality occurred in one IPFT patient (2.5%), attributed to unrelated aspiration pneumonia. IPFT and intrapleural saline irrigation are safe and effective adjuncts in pleural infection management, with comparable short-term outcomes. In centres where IPFT is unavailable, saline irrigation may be a reasonable alternative. Larger multicentre trials are needed to confirm these findings. The study was registered with Clinical Trials number (NCT05903417) on 15.06.2023.