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Saline Irrigation for Pleural Infections (LYTICS +)

This study is looking at whether adding saline irrigation to standard treatment can help people with retained pleural infections. These infections cause fluid buildup around the lungs (pleural effusion) and are often treated with antibiotics, a chest tube, and special medications called intrapleural tPA/DNase (IPFT). The study will give some participants standard care, while others will also receive up to 250 mL of sterile saline solution flushed into their chest tube after each IPFT session. Researchers will measure the amount of fluid around the lungs at different times to see if the saline irrigation helps reduce it. You might be able to join if you are 18 or older, have a pleural infection with specific fluid test results (like low pH or high LDH), and need IPFT treatment. The study aims to enroll 96 participants, but its current recruitment status is unclear.

Study design
This is a prospective, two-arm pilot trial where participants will be randomly assigned to receive either standard care or standard care plus saline irrigation. The study plans to enroll 96 participants.
What's involved
Participants will receive either standard care or standard care plus saline irrigation through a chest tube, repeated each time IPFT is given. Fluid volume will be measured at baseline, during hospitalization, at discharge, and at 3 and 6 weeks after starting the intervention.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up at 3 weeks (+/- 3 days) and 6 weeks (+/- 3 days) after the intervention starts.

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NCT06713382

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Beth Israel Deaconess Medical Center
~96 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Pleural Saline Irrigation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduction in Pleural Effusion Volume
Measured over Baseline (prior to intervention). During hospitalization (before each IPFT and irrigation session, anticipated every 24 hours, up to 14 days). At discharge (7-14 days post-intervention initiation). Follow-up at 3 weeks (+/- 3 days) and 6 weeks (+/- 3 day

Conditions

Pleural Effusion Associated With Pulmonary Infection
Pleural Effusion Disorder
Pleural Effusions

Explore related trials

Pleural EffusionPleural Infection

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Adnan Majid, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center

Who to contact

Adnan Majid, MD
[email protected]
6179016430
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Reduction in Pleural Effusion VolumeBaseline (prior to intervention). During hospitalization (before each IPFT and irrigation session, anticipated every 24 hours, up to 14 days). At discharge (7-14 days post-intervention initiation). Follow-up at 3 weeks (+/- 3 days) and 6 weeks (+/- 3 day

    This outcome assesses the percentage reduction in pleural effusion volume from baseline, measured by CT (volumetry) and ultrasound using the Balik formula. Efficacy is defined as a 10% or greater improvement in pleural effusion volume reduction in the intervention group (standard care plus pleural saline irrigation) compared to the control group (standard care alone). Success is determined by achieving a ≥10% additional reduction in pleural effusion volume in the intervention group compared to the control group, indicating a clinically meaningful improvement with adjunctive saline irrigation.