Trial · NCT06713382
Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]
NCT06713382, Phase 2, Recruiting, Beth Israel Deaconess Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]. Trials, record NCT06713382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06713382
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Efficacy and Safety of Saline Irrigation as an Add-On Therapy for Retained Pleural Infections [LYTICS +]
- NCT number
- NCT06713382
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 96 participants, estimated
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Pleural Effusion Associated With Pulmonary Infection, Pleural Effusion Disorder, Pleural Effusions
- Interventions
- Pleural Saline Irrigation
- First posted
- 2024-12-03
- Last updated
- 2026-08-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction in Pleural Effusion Volume | 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 | 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. |
| Secondary | Rate of pleural infection resolution | Baseline, at discharge (7-14 days post-intervention initiation), and follow-up (3 weeks +/- 3 days and 6 weeks +/- 3 days post-discharge). | Determined through clinical markers (fever resolution), radiographic improvement (ultrasound and CT signs of effusion), and laboratory indicators (inflammatory markers and blood cultures). |
| Secondary | Chest tube duration | Through hospitalization (up to 14 days). | Total duration of chest tube placement from insertion to removal. |
| Secondary | Length of hospital stay | Through hospitalization (anticipated 7-14 days). | Total length of stay from admission to discharge. |
| Secondary | Complications related to the interventions | During hospitalization (up to 14 days) and at follow-up (3 weeks +/- 3 days and 6 weeks +/- 3 days post-discharge). | Includes adverse events such as hypothermia, chest discomfort, fluid overload, and infection recurrence. |
| Secondary | Pain associated with interventions | During hospitalization (measured immediately after each intervention session, anticipated up to 14 days). | Level of pain reported during procedures, measured using a standardized pain scale (e.g., Visual Analog Scale). |
| Secondary | Need for surgical intervention | Through study completion (up to 6 weeks post-discharge). | Incidence of surgical intervention required due to unresolved pleural infection or complications. |
| Secondary | Overall mortality | Through study completion (up to 6 weeks post-discharge). | Death from any cause during the study period. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06713382
GET https://conductscience.org/api/trials/v1/NCT06713382/registered