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NCT06713382 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]
A Phase 2 study of Pleural Effusion Disorder and Pleural Effusion Associated With Pulmonary Infection, sponsored by Beth Israel Deaconess Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT06713382: Recruiting Phase 2 study of Pleural Effusion Disorder and Pleural Effusion Associated With Pulmonary Infection, sponsored by Beth Israel Deaconess Medical Center.
NCT06713382 is a Phase 2 study of Pleural Effusion Disorder and Pleural Effusion Associated With Pulmonary Infection that is actively recruiting participants, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 96 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06713382, a Phase 2 study of Pleural Effusion Disorder and Pleural Effusion Associated With Pulmonary Infection, is actively recruiting participants, sponsored by Beth Israel Deaconess Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 t
Conditions Studied
Interventions
- COMBINATION_PRODUCT Pleural Saline Irrigation
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2025-04-10 |
| Est. Completion | 2026-12-20 |
| Phase | Phase 2 |
What NCT06713382 shows while recruiting
NCT06713382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower).
The record links to 3 conditions, with Pleural Effusion Disorder appearing as the primary indexed condition, and to 1 intervention - of which Pleural Saline Irrigation is the first listed.
NCT06713382 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06713382 about?
NCT06713382 is a clinical study titled "Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]". 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 us...
What is the current status of trial NCT06713382?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2025-04-10. Estimated completion is 2026-12-20.
What conditions does trial NCT06713382 study?
This clinical trial studies the following conditions: Pleural Effusion Disorder, Pleural Effusion Associated With Pulmonary Infection, Pleural Effusions.
What interventions are being tested in trial NCT06713382?
The interventions under investigation include: Pleural Saline Irrigation (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06713382?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06713382 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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96 747th of 2000 higher than 1,243 of 2,000 other Phase 2 trials
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