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

RecruitingPhase 2Ages 18 Years - anyAllBeth Israel Deaconess Medical Center
NCT06713382 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 comb

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years. * Presence of purulent pleural fluid or pleural fluid analysis with any of the following: * pH ≤ 7.2. * Glucose \< 40 mg/dL. * LDH \> 1000 IU/L. * Presence of bacterial or fungal organisms on Gram stain or culture. * Chest tube placement with less than 200 mL drainage in 24 hours. * Indication for IPFT treatment based on treating physician's criteria. * Radiographic evidence of septations on chest ultrasound (US) or loculations on low-dose chest computed tomography (CT). Exclusion Criteria: * Inability to provide informed consent. * Pregnant patients. * Patients with significant comorbidities that may interfere with the study -outcomes (e.g., terminal malignancy). * Complicated sympathetic effusion. * Hepatic hydrothorax.
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What it tests

  • Pleural Saline Irrigation
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Where

1 site
Beth Israel Deaconess Medical Center
Boston, United States
🤝 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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