Saline Irrigation for Bacterial Pleural Effusion

([LYTICS+] Trial)

Overseen By Adnan Majid, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Pregnancy, Terminal malignancy, others

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 7-14 days

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether pleural saline irrigation, a new use of saltwater, can help treat stubborn lung infections with fluid buildup around the lungs. Researchers aim to determine if adding saltwater rinses to standard treatment improves recovery when typical methods fall short. This trial targets adults with lung infections not fully treated by antibiotics, who have a chest tube but still experience poor drainage. Participants must have confirmed infections and specific fluid characteristics, such as low pH or glucose levels, and visible fluid pockets on scans. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in lung infection treatment.

Will I have to stop taking my current medications?

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 this saline irrigation technique is safe for treating pleural infections?

A previous study showed that patients who received saline irrigation experienced a significant decrease in fluid around their lungs, as seen on CT scans. This suggests that the treatment clears fluid more effectively than standard care alone. Other research found a 32.3% reduction in lung fluid with saline irrigation, compared to just 15.3% in those who didn't receive this treatment.

Reports also indicate that people who received saline irrigation had fewer complications and needed fewer surgeries, demonstrating its safety. These findings suggest that saline irrigation is not only effective but also well-tolerated by patients, making it a promising option for those with pleural infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pleural saline irrigation for bacterial pleural effusion because it offers a new approach to an existing problem. Unlike the standard care options, which include antibiotics, chest tube placement, and intrapleural tPA/DNase therapy, pleural saline irrigation involves flushing the pleural space with saline through a chest tube. This method could enhance the effectiveness of the current treatments by potentially improving fluid drainage and reducing infection more efficiently. By integrating saline irrigation with standard care, there is hope that this technique will lead to faster recovery and better outcomes for patients.

What evidence suggests that this saline irrigation technique is effective for bacterial pleural effusion?

Research has shown that using a saltwater rinse, known as saline irrigation, can help treat pleural infections when combined with standard treatments. In this trial, one group of participants will receive standard care, including antibiotics, chest tube placement, and intrapleural tPA/DNase therapy. Another group will receive the same standard care plus saline irrigation. Studies have found that patients who received saline irrigation had less fluid in their lungs, as seen on CT scans, indicating a decrease in infection. Saline irrigation helps by washing away bacteria and other harmful substances from the lung area, which may aid the body's healing process. Some patients have shown improvement and recovered better with this method. Observations also suggest that saline irrigation can be helpful when other treatments haven't worked. Overall, early findings support the idea that saline irrigation could be a promising addition for treating difficult pleural infections. ^{1 3 5 6 7}

Who Is on the Research Team?

Adnan Majid, MD FCCP

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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

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)

My pleural fluid is infected or has low glucose levels.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard care or standard care plus saline irrigation for retained pleural infections

7-14 days

Daily interventions during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Follow-up visits at 3 weeks and 6 weeks post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Pleural Saline Irrigation

Trial Overview

The 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.

How Is the Trial Designed?

Group I: Standard Care + Saline Irrigation Experimental Treatment 1 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 care Active Control 1 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

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

In a study of 127 adults with chronic nasal and sinus symptoms, nasal irrigations using large volumes and low positive pressure significantly improved quality of life, as shown by lower SNOT-20 scores compared to saline sprays over an 8-week period.

At the 8-week mark, only 40% of patients using the irrigation method reported frequent symptoms, compared to 61% in the spray group, indicating that the irrigation method was more effective in reducing symptom frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. Pynnonen, MA., Mukerji, SS., Kim, HM., et al.[2015]

In a study involving 60 patients over 17 days, a sodium chloride nasal gel at a concentration of 6.0mg/g was found to provide greater comfort and less stinging sensation compared to a 4.5mg/g concentration.

Both concentrations of the nasal gel did not show a significant difference in humidification effectiveness, indicating that while comfort levels varied, the ability to humidify the nasal passages remained consistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Ringer's lactate gel formulation on nasal comfort and humidification. Neves, MCD., Romano, FR., Guerra Filho, S.[2022]

Citations

1.

publications.ersnet.org

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

Pleural irrigation trial (PIT): a randomised controlled trial of ...

Patients receiving saline irrigation had a significantly greater reduction in pleural collection volume on computed tomography compared to those receiving ...

2.

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 ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06434324

Pleural Space Saline Irrigation in Addition to Standard ...

Saline irrigation of the pleural space has been proposed to reduce stasis and dilute bacteria, cytokines, and coagulation factors, which induce pleural space ...

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/rcr2.70000

A potential prospect: The novel treatment of intrapleural ...

Upon follow-up, both cases showed clinical cure, biochemical recovery, and radiological improvement, indicating a good treatment outcome. This ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0954611121004145

Optimizing the management of complicated pleural effusion

Observational studies demonstrated good therapeutic efficacy in PPE/empyema when performed as first-line procedure or after a chest tube treatment failure, ...

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 ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0954611121002596

Review article Evaluation and management of pleural sepsis

Patients who received intrapleural saline irrigation demonstrated significant reduction in pleural fluid volume on CT and significant reduction in surgical ...