Saline Irrigation for Bacterial Pleural Effusion
([LYTICS+] Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAdnan Majid, MD FCCP

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Beth Israel Deaconess Medical Center

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No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Adnan Majid, MD FCCP

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for patients with persistent pleural infections who haven't responded well to antibiotics and tube drainage. It's not suitable for those at high risk of bleeding where standard therapy using intrapleural fibrinolytic therapy (IPFT) isn't safe.

Inclusion Criteria

My pleural fluid is infected or has low glucose levels.

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)

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Exclusion Criteria

I do not have other major health issues that could affect the study.

I am unable to understand or sign the consent form.

I have a complex fluid buildup due to inflammation.

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Treatment Details

Interventions

Pleural Saline Irrigation (Other)

Trial OverviewThe study tests if adding saline irrigation to IPFT can improve outcomes in treating retained pleural infections. Patients will be compared based on inflammation levels, imaging results, fluid drained, chest tube time, hospital stay length, and need for surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard Care + Saline IrrigationExperimental Treatment1 Intervention

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

Group II: Standard of careActive Control1 Intervention

Patients will receive the current standard of care, which includes antibiotics, chest tube placement, and intrapleural tPA/DNase therapy based on their clinical criteria