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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Adnan Majid, MD
amajid@bidmc.harvard.edu
6179016430
Backup
Maria C Lopez, MD
mlopezgi@bidmc.harvard.edu
7869678448
Time Frame
Start Date: 2025-04-10
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 96
Treatments
No_intervention: Standard of care
Patients will receive the current standard of care, which includes antibiotics, chest tube placement, and intrapleural tPA/DNase therapy based on their clinical criteria
Experimental: Standard Care + Saline Irrigation
In addition to the standard care, patients in this group will receive pleural saline irrigation through the chest tube immediately after IPFT. The amount of saline will be determined by free-flow saline infusion up to 250 mL. This maneuver will be repeated every time that IPFT is administered, based on treating physician's criteria
Related Therapeutic Areas
Sponsors
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov