Saline Irrigation for Empyema

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Bleeding diathesis, Pregnancy, Incarceration, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 3-14 days

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding saline irrigation (a saltwater cleanse) through a chest tube aids in treating pleural space infections, which occur around the lungs. Participants will receive either the standard treatment or the standard treatment plus saline irrigation. Suitable candidates for this trial have a suspected or confirmed lung infection and are beginning a specific treatment at the Mayo Clinic in Rochester, MN. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial requires that you stop taking systemic anticoagulation or antiplatelet therapy unless you can pause it for the recommended time before an invasive procedure. However, taking aspirin alone is allowed.

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

Research has shown that using a saltwater rinse to treat chest infections is generally safe and well-tolerated. Studies have found that patients receiving this treatment experienced less fluid buildup in their chest, indicating its effectiveness.

In another report, two cases of chest infections were successfully treated with saltwater rinses, demonstrating positive results. While these findings are encouraging, some studies found the treatment ineffective for 13.3% of patients, many of whom had cancer. This suggests that while the treatment is safe, it may not be effective for everyone.

Overall, saltwater rinses are considered safe for most people, but individual reactions can vary. Always consult a doctor about potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using saline irrigation for treating empyema because it offers a new approach to clearing the pleural space. Unlike the standard of care, which generally includes fibrinolytic therapy to break down fibrous tissue, this method adds a daily saline rinse through the chest tube. This combination could potentially enhance the evacuation of fluid and debris more effectively than fibrinolytics alone. By improving how well and quickly the pleural space is cleared, saline irrigation could lead to faster recovery times and better outcomes for patients.

What evidence suggests that saline irrigation might be an effective treatment for pleural space infection?

In this trial, participants in the Saline Irrigation Group will receive a saltwater rinse alongside standard treatment for pleural empyema. Studies have shown that adding a saltwater rinse can reduce chest fluid by 32.3%, compared to a 15.3% reduction with standard treatment alone. One study found that a saltwater rinse might be a safe alternative to surgery for empyema patients. However, it may not be as effective for empyema caused by other factors, showing a 69% success rate. Overall, using a saltwater rinse appears to be a promising option for managing pleural empyema. ^{2 5 6 7 8}

Who Is on the Research Team?

Dagny Anderson, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals suspected or confirmed to have a pleural space infection, which includes conditions like empyema or complicated parapneumonic effusion.

Inclusion Criteria

I am starting treatment for fluid in my chest at Mayo Clinic in Rochester, MN.

My pleural fluid test shows infection or very low pH and glucose levels.

Exclusion Criteria

Platelet count <50,000 per μL

Current or recent (within past 30 days) presence of tunneled pleural catheter on the same side as the current proven/suspected pleural space infection

Unwillingness to give informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive twice daily fibrinolytic therapy with or without saline irrigation through their chest tube until adequate pleural space evacuation is achieved

Approximately 3-14 days

Daily monitoring (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and need for additional interventions

10 days

What Are the Treatments Tested in This Trial?

Interventions

• Saline Irrigation

Trial Overview The study aims to determine if adding saline irrigation through a chest tube provides any benefits over the standard treatment for pleural space infections.

How Is the Trial Designed?

Group I: Saline Irrigation Group Experimental Treatment 1 Intervention

Subjects will receive twice daily fibrinolytic therapy in addition to daily saline irrigation through their chest tube until the treating physician determines that the pleural space has been adequately evacuated

Group II: Standard of Care Group Active Control 1 Intervention

Subjects will receive twice daily fibrinolytic therapy through their chest tube until the treating physician determines that the pleural space has been adequately evacuated

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A new irrigation method for treating pleural empyema and pneumonectomy space infections was effective, eradicating infections in an average of 11 days for most patients, including those with complex conditions like bronchopleural fistulas.

Compared to traditional treatments over a 10-year period, this irrigation technique led to shorter hospital stays and reduced wound drainage times, suggesting it may be a more efficient option for managing these infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between irrigation and conventional treatment for empyema and pneumonectomy space infection. Rosenfeldt, FL., McGibney, D., Braimbridge, MV., et al.[2019]

A new irrigation technique for managing empyema thoracis was successfully implemented in 14 patients, involving initial thoracoscopy for direct debridement and subsequent irrigation until cultures of the drained fluid were sterile.

The average duration of irrigation was 14 days, and patients had an average hospital stay of 4.8 weeks, indicating that this method is effective and can be used even in cases of tuberculous empyema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The management of empyema thoracis by thoracoscopy and irrigation. Lema, L., Hutter, JA., Harari, D., et al.[2013]

A new irrigation technique for managing empyema was successfully used in 12 patients, allowing for thorough cleaning and drainage of the empyema cavity after initial thoracoscopy.

Patients required an average of 14 days of irrigation and had chest drains removed after about 20 days, with an overall hospital stay averaging 4.8 weeks, indicating a structured and effective approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The management of empyema thoracis by thoracoscopy and irrigation. Hutter, JA., Harari, D., Braimbridge, MV.[2019]

In a study of 42 patients with pleural empyema, serial thoracocentesis combined with saline irrigation was highly effective for treating empyema resulting from pneumonia, achieving an 86% success rate without needing more invasive procedures.

The treatment was less effective for empyema caused by other factors, with only a 69% success rate and a significant crossover to more invasive therapies, indicating that different approaches may be necessary for non-pneumonic cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive treatment of thoracic empyema. Simmers, TA., Jie, C., Sie, B.[2014]

Saline nasal irrigation (SNI) has been shown to provide benefits for certain rhinological symptoms in infants and children with acute rhinopharyngitis, based on a systematic review of 4 randomized control trials involving 569 participants.

While SNI did not significantly improve respiratory symptoms or overall health status, it was associated with a reduction in the need for other treatments, including antibiotics, and appeared to be a safe option for managing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saline nasal irrigation for acute upper respiratory tract infections in infants and children: A systematic review and meta-analysis. Cabaillot, A., Vorilhon, P., Roca, M., et al.[2021]

In a study of 20 patients with para-pneumonic empyema, the use of electrolyzed saline (ES) for intra-pleural irrigation led to successful pleural disinfection in 90% of cases, demonstrating its efficacy in treating this condition.

The procedure was safe, with no reported chest pain during irrigation and a high discharge rate of 95%, indicating that ES irrigation is a promising method for managing empyema without the need for more invasive drainage procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrolyzed Saline Irrigation for Elimination of Bacterial Colonization in the Empyema Space. Nakamoto, K., Takeshige, M., Fujii, T., et al.[2018]

In a study of 204 women undergoing primary cesarean sections, subcutaneous saline irrigation did not significantly reduce the rates of superficial surgical site infections (SSI) compared to the control group (14.3% vs 12.8%).

However, the saline irrigation group experienced significantly lower occurrences of hematoma and seroma, suggesting that while it may not prevent infections, it can help reduce other wound complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of subcutaneous irrigation on wound complications after cesarean sections: A prospective randomised study. Aslan Çetin, B., Aydogan Mathyk, B., Barut, S., et al.[2018]

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]

Saline irrigation (SI) is a common treatment for nasal issues, working through mechanisms like clearing mucus, improving mucociliary function, and enhancing the antimicrobial properties of nasal secretions, but its effectiveness is not strongly supported by current evidence.

While SI is generally safe, it can cause side effects such as nasal discomfort and otalgia, and there are concerns about contamination of solutions, highlighting the need for more research, especially in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of nasal saline irrigation in nasal inflammatory diseases]. Tan, L., Xu, Y.[2019]

In a study of 65 COPD patients undergoing sputum induction with normal and hypertonic saline, most patients did not experience major adverse events, although some reported increased dyspnea and discomfort, particularly those with more advanced disease.

The study found that baseline lung function measures, such as FEV1 and oxygen saturation, can help predict which patients might experience adverse reactions during the sputum induction procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyspnea assessment and adverse events during sputum induction in COPD. Makris, D., Tzanakis, N., Moschandreas, J., et al.[2018]

Videothoracoscopic debridement combined with postoperative antibiotic irrigation is an effective treatment for postpneumonectomy empyema, as demonstrated in a study of 9 patients with no observed recurrence of empyema or tumor during a follow-up period averaging over 21 months.

The procedure was safe, with no postoperative mortality or significant morbidity, and it successfully addressed concomitant bronchopleural fistulas when they were small enough to be closed bronchoscopically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Videothoracoscopic debridement of the postpneumonectomy space in empyema. Hollaus, PH., Lax, F., Wurnig, PN., et al.[2019]

Citations

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

The novel treatment of intrapleural saline irrigation with ... We report two cases of thoracic empyema that were successfully treated with intrapleural saline irrigation and intrapleural tyloxapol apart from parenteral ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06434324?term=AREA%5BConditionSearch%5D(%22Pleural%20Empyema%22)%20AND%20AREA%5BInterventionSearch%5D(%22fibrinolytic%20agents%22)&rank=4

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 ...

3. withpower.com withpower.com/trial/phase-empyema-6-2024-df9b1

Saline Irrigation for Empyema The treatment was less effective for empyema caused by other factors, with only a 69% success rate and a significant crossover to more invasive therapies, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12276064/

Effective Treatment of Empyema With Fistula Using Saline ... Conclusions. This case demonstrates that intrapleural saline irrigation may serve as an effective and safe alternative to surgical intervention ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/crj.13415

Saline lavage for the management of severe pleural ... Our study reports the efficacy and safety of pleural lavage with saline solution in patients with pleural empyema including those with ...

6. 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 ...

7. 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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06434324

Pleural Space Saline Irrigation in Addition to Standard ... To our knowledge, the efficacy of intrapleural saline irrigation in addition to fibrinolytic therapy has not been studied in comparison to fibrinolytic therapy ...