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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if there is any benefit in adding saline irrigation through a chest tube to the standard course of treatment for people diagnosed or suspected of having a pleural space infection.

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 data supports the effectiveness of the treatment Saline Irrigation for empyema?

Research shows that saline irrigation can be effective in treating empyema, especially when combined with other procedures like thoracoscopy (a procedure to look inside the chest). It helps clean the infected area, and studies have shown it can lead to successful outcomes when used properly. ^{1 2 3 4 5}

Is saline irrigation generally safe for humans?

Saline irrigation is generally safe for humans, but it can cause minor side effects like nasal discomfort, ear pain, and pooling of saline in the sinuses. There is also a risk of contamination if the solution is not handled properly. ^{2 6 7 8 9}

How does saline irrigation differ from other treatments for empyema?

Saline irrigation for empyema is unique because it involves using a saltwater solution to wash out the infected area, which can rapidly disinfect the space and potentially shorten hospital stays compared to traditional methods like aspiration or open drainage. ^{1 4 5 10 11}

Research Team

Dagny Anderson, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Minimally invasive treatment of thoracic empyema. [2014]

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

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

3. Germany pubmed.ncbi.nlm.nih.gov

Videothoracoscopic debridement of the postpneumonectomy space in empyema. [2019]

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

Electrolyzed Saline Irrigation for Elimination of Bacterial Colonization in the Empyema Space. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The management of empyema thoracis by thoracoscopy and irrigation. [2019]

6. China pubmed.ncbi.nlm.nih.gov

[Application of nasal saline irrigation in nasal inflammatory diseases]. [2019]

7. Ireland pubmed.ncbi.nlm.nih.gov

The impact of subcutaneous irrigation on wound complications after cesarean sections: A prospective randomised study. [2018]

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

Saline nasal irrigation for acute upper respiratory tract infections in infants and children: A systematic review and meta-analysis. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Dyspnea assessment and adverse events during sputum induction in COPD. [2018]

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

Comparison between irrigation and conventional treatment for empyema and pneumonectomy space infection. [2019]

11. Zimbabwe pubmed.ncbi.nlm.nih.gov

The management of empyema thoracis by thoracoscopy and irrigation. [2013]