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

Trial Summary

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 data supports the effectiveness of the treatment Pleural Saline Irrigation for bacterial pleural effusion?

Saline irrigation has been shown to be effective in reducing bacterial infections in other areas, such as the sinuses and abdominal infections, by helping to wash away bacteria and debris. Although not directly studied for pleural effusion, its use in similar contexts suggests it may help in managing bacterial pleural effusion. ^{1 2 3 4 5}

How does saline irrigation differ from other treatments for bacterial pleural effusion?

Saline irrigation for bacterial pleural effusion involves flushing the pleural space with saline (a saltwater solution) three times a day for three days, which is different from standard care that does not include this step. This method has shown a greater reduction in pleural fluid volume compared to standard care alone, potentially reducing the need for surgery. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Adnan Majid, MD FCCP

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

My pleural fluid is infected or has low glucose levels.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Comparison of antibiotics and saline irrigation with tube drainage in the treatment of postoperative abdominal and pelvic infectious effusion]. [2020]

2. Japan pubmed.ncbi.nlm.nih.gov

[Pleural washing with povidone-iodine for treatment of empyema]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

The impact of intraoperative saline irrigations on bacterial load within the maxillary sinus. [2021]

5. Brazil pubmed.ncbi.nlm.nih.gov

New Ringer's lactate gel formulation on nasal comfort and humidification. [2022]

6. Poland pubmed.ncbi.nlm.nih.gov

[Microflora colonizing pleural drains after thoracic surgery]. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Saline lavage for the management of severe pleural empyema: A cohort study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Pleural irrigation trial (PIT): a randomised controlled trial of pleural irrigation with normal saline versus standard care in patients with pleural infection. [2018]

9. Spain pubmed.ncbi.nlm.nih.gov

[Pleurodesis with tetracycline in neoplastic effusions. Is an acid pH necessary?]. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Streptococcus pneumoniae sepsis in a pleural effusion smear with concomitant Waldenstrom's macroglobulinemia. [2020]