Saline Irrigation for Pleural Effusion

Overseen By Christine Conley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Malignancy, Post-procedural empyema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called intrapleural saline irrigation for individuals with pleural effusion, a condition where fluid accumulates around the lungs. The goal is to determine if saline (saltwater) flushing can benefit those unable to use standard enzyme treatments. Suitable candidates have been diagnosed with retained pleural effusion by ultrasound and cannot receive standard enzyme therapy after chest tube insertion. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new treatment options for pleural effusion.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that intrapleural saline irrigation is safe for treating pleural infections?

Research has shown that washing the space around the lungs with a saltwater solution is generally safe and well-tolerated. Previous studies have found that this treatment can lead to positive outcomes, such as reducing fluid around the lungs and improving symptoms. For instance, one study found a 32.3% decrease in lung fluid compared to standard care. Another study reported that patients treated with saltwater washing experienced recovery and improvement. These findings suggest that this method might be a safe option, especially for those who cannot undergo standard treatments. Overall, past research indicates that the treatment appears promising in terms of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Intrapleural saline irrigation is unique because it offers a potentially simpler and less invasive way to manage pleural effusion compared to the standard treatments like thoracentesis or pleurodesis. Unlike these traditional methods that physically remove fluid or chemically adhere the lung to the chest wall, saline irrigation works by flushing the pleural space, which could reduce fluid buildup and inflammation. Researchers are excited about this approach because it might improve patient comfort and outcomes with fewer complications and quicker recovery times.

What evidence suggests that intrapleural saline irrigation might be an effective treatment for pleural effusion?

Studies have shown that washing the chest area with a saltwater solution can help treat lung infections. In some cases, patients improved, and their scans showed positive changes. Research indicates that this treatment can reduce lung fluid by 32.3%, compared to 15.3% with regular treatment. Using saltwater also clears lung fluid faster, which is important for managing infections. Early findings suggest it might be a simple and cost-effective option. Participants in this trial will receive intrapleural saline irrigation to evaluate its effectiveness in treating pleural effusion. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for patients who have pleural effusion (fluid build-up between the lungs and chest) that remains after a chest tube insertion, and cannot receive standard enzyme treatments due to contraindications.

Inclusion Criteria

I have fluid in my chest found by ultrasound within a day after getting a chest tube.

I cannot receive certain chest treatments within 24 hours after a chest tube is placed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intrapleural saline irrigation to treat retained pleural infections

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intrapleural Saline Irrigation

Trial Overview The study is testing a new method called intrapleural saline irrigation using the CLR irrigator device. It's designed to treat retained infections in the pleural space when standard therapies aren't suitable.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11316260/

The novel treatment of intrapleural saline irrigation with ... Upon follow‐up, both cases showed clinical cure, biochemical recovery, and radiological improvement, indicating a good treatment outcome. This is the first ...

2. publications.ersnet.org publications.ersnet.org/content/erj/46/2/456

Pleural irrigation trial (PIT): a randomised controlled trial of ... We hypothesised that intrapleural saline irrigation would improve pleural fluid drainage and resolution of sepsis as part of the conservative management of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06434324

Pleural Space Saline Irrigation in Addition to Standard ... Saline irrigation led to a 32.3% reduction in pleural fluid volume as assessed by computed tomography in comparison to 15.3% in the standard care arm. Fewer ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0954611121004145

Optimizing the management of complicated pleural effusion Interestingly, a pilot study demonstrated that saline irrigation might be a simple and cost-effective alternative to intrapleural antifibrinolytics.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5549865/

Pleural Diseases: Saline Irrigation in Pleural Infection ... Patients receiving saline irrigation had a significantly greater reduction in the volume of their pleural collection seen on CT scans at Day 3 than those ...

6. alicantobidmc.org alicantobidmc.org/resources/evaluating-efficacy-and-safety-saline-irrigation-add-therapy-retained-pleural-infections

Evaluating the Efficacy and Safety of Saline Irrigation as an ... The primary outcome is the reduction in pleural effusion volume, measured with CT (volumetry) and US (Balik formula), with efficacy defined as a ...