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

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

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• Pleural Saline Irrigation (combination product)

Sponsor: Beth Israel Deaconess Medical Center · Participants: 96 · Started: Apr 10, 2025

Contact the study team

• Adnan Majid, MD · Phone: 6179016430
• Maria C Lopez, MD · Phone: 7869678448

Official record on ClinicalTrials.gov — NCT06713382

Locations in the U.S.

Conditions

• Pleural Effusion

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.