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Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]

Study acronym: [LYTICS+]
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Completion pushed from Dec 20, 2026 to Jan 20, 2027v4
  2. Notable Primary completion date: Sep 20, 2025 to Nov 20, 2026 Completion date: Dec 20, 2025 to Dec 20, 2026 · Start date changed from estimate of Mar 10, 2025 to Apr 10, 2025v3 Show 2 more changesShow less
    • Completion date: Dec 20, 2025 to Dec 20, 2026
    • Start date changed from estimate of Mar 10, 2025 to Apr 10, 2025
  3. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Dec 20, 2024 to Mar 10, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Dec 20, 2024 to Mar 10, 2025
    • Site details revised
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this protocol is to conduct a pilot prospective non-blind clinical trial to evaluate the efficacy and safety of a novel saline irrigation technique as an adjunct to standard interventions for treating retained pleural infections. Intrapleural fibrinolytic therapy (IPFT) is commonly used for infections not adequately managed with antibiotics and intercostal tube drainage, while saline irrigation serves as an alternative for cases with a high bleeding risk where IPFT is not feasible. The efficacy of saline irrigation combined with IPFT remains unexplored. The hypothesis is that saline irrigation could be an effective and safe addition to IPFT for patients with persistent pleural infections. The specific aims of the study include: Determine the efficacy of saline irrigation as add-on therapy to IPFT: Compare the clinical outcomes of patients receiving saline irrigation combined with IPFT to those receiving IPFT alone to determine if the addition of saline irrigation offers significant benefits. Outcomes include changes in inflammatory markers, imaging characteristics (echography and CT), volume of pleural fluid drained, chest tube duration, hospital length of stay, and the need for subsequent surgical intervention. Assess the safety and tolerability of saline irrigation plus IPFT: Compare complications and patient comfort in those receiving saline irrigation combined with IPFT to those receiving IPFT alone.
Trial Details
NCT Number NCT06713382
Lead Sponsor Beth Israel Deaconess Medical Center
Conditions Pleural Effusion Associated With Pulmonary Infection, Pleural Effusion Disorder, Pleural Effusions
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov