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Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]
Sponsor: Beth Israel Deaconess Medical Center
Summary
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.
Official title: Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections (LYTICS +)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2025-04-10
Completion Date
2026-12-20
Last Updated
2025-05-25
Healthy Volunteers
No
Conditions
Interventions
Pleural Saline Irrigation
This intervention, Pleural Saline Irrigation, involves the administration of up to 250 mL of sterile saline solution into the pleural cavity through a chest tube immediately following each intrapleural tPA/DNase (IPFT) therapy session. The saline irrigation is intended to aid in clearing infected pleural fluid and reducing pleural effusion volume. This maneuver is repeated based on the treating physician's criteria, differentiating it from standard care, which includes only antibiotics, chest tube placement, and IPFT without saline irrigation. The irrigation is expected to enhance infection resolution and may impact chest tube duration and the frequency of pleural interventions.
Locations (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States