Recruiting
Phase 2

Saline Irrigation

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06713382

Conditions

Pleural Effusion Associated With Pulmonary Infection

Pleural Effusion Disorder

Pleural Effusions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pleural Saline Irrigation

Study Details

Brief 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.

Conditions

Pleural Effusion Associated With Pulmonary Infection

Pleural Effusion Disorder

Pleural Effusions

Study ID

NCT06713382

Start date

Apr 10, 2025

Status verified date

Aug, 2026

Completion date

Jan 20, 2027

Anticipated

Primary completion date

Nov 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of care

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

experimental: Standard Care + Saline Irrigation

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

Interventions

Pleural Saline Irrigation

This intervention, Pleural Saline Irrigation, involves the administration of up to 250 mL of sterile saline solution into the pleural cavity through a chest tube immediately following each intrapleural tPA/DNase (IPFT) therapy session. The saline irrigation is intended to aid in clearing infected pleural fluid and reducing pleural effusion volume. This maneuver is repeated based on the treating physician's criteria, differentiating it from standard care, which includes only antibiotics, chest tube placement, and IPFT without saline irrigation. The irrigation is expected to enhance infection resolution and may impact chest tube duration and the frequency of pleural interventions.

Primary outcome measure

  • Reduction in Pleural Effusion Volume [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Adnan Majid, MD

6179016430amajid@bidmc.harvard.edu

Maria C Lopez, MD

7869678448mlopezgi@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Adnan Majid, MD

6179016430amajid@bidmc.harvard.edu

Principal Investigator:

Adnan Majid, MD

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Pleural Effusion
  • Thoracentesis
  • Tissue Plasminogen Activator
  • DNase
  • Therapeutic Irrigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-08-28.