Intrapleural use of tissue plasminogen activator and DNase in pleural infection.
Najib M Rahman, Nicholas A Maskell, Alex West...
https://pubmed.ncbi.nlm.nih.gov/21830966/Actively Recruiting
Led by Mayo Clinic · Updated on 2026-03-30
60
Participants Needed
1
Research Sites
12 weeks
Total Duration
Researchers are evaluating whether adding saline irrigation through a chest tube to the standard treatment improves outcomes for people diagnosed or suspected of having a pleural space infection, such as empyema or complicated parapneumonic effusion. This condition often leads to significant illness requiring procedures or surgery and extended hospital stays. Previous studies have shown benefits using intrapleural thrombolytic therapy, and saline irrigation may help reduce infection and fluid buildup by diluting harmful substances in the pleural space. Participants will be randomly assigned to one of two groups. One group will receive standard intrapleural fibrinolytic therapy twice daily through a chest tube. The other group will receive the same fibrinolytic therapy plus daily saline irrigation of up to 250 cc through their chest tube until the pleural space is adequately drained, as determined by the treating physician. This study is conducted by the Mayo Clinic and focuses on hospitalized patients managed by their interventional pulmonary service. During the study, participants will be monitored for adequate chest fluid evacuation, need for further interventions, duration of chest tube use, hospital stay length, pain associated with saline irrigation, and any adverse events. These assessments will take place over approximately 3 to 14 days. The study includes regular clinical evaluations and imaging to measure treatment effects and safety. Participants involvement will last for the duration of their hospital stay related to the infection and treatment.
CONDITIONS
Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in Empyema/Complicated Parapneumonic Effusion
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Mayo Clinic
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Saline Irrigation Group | Standard of Care Group |
|---|---|---|
| What it is | Daily warmed saline irrigation through thoracostomy tube (up to 2,000 cc), given in addition to standard intrapleural thrombolytic therapy. | Standard intrapleural thrombolytic therapy alone, without additional saline irrigation. |
| Role in the trial | Investigational treatment arm assessing whether adding saline irrigation improves pleural space evacuation. | Comparator arm representing current local standard intrapleural lytic practice. |
| Primary use | Aims to enhance pleural space evacuation beyond thrombolytics alone by mechanically irrigating and clearing infected material. | Used to promote drainage and clearance of infected pleural collections through enzymatic breakdown of fibrin and pus. |
| How it is given or performed | Warmed saline is instilled daily in 250 cc intervals (up to 2,000 cc) through the thoracostomy tube as part of routine catheter care. | Intrapleural thrombolytic agents are delivered through existing thoracostomy tubes following local protocols. |
| Evidence status | Current evidence is limited; previous studies suggest potential safety and feasibility but lack robust efficacy data for saline irrigation as adjunct. | Thrombolytic therapy is supported by randomized trials and guideline recommendations for efficacy in promoting drainage and improving outcomes in pleural infection. |
| Important limitations | Clinical benefit of saline irrigation remains unproven. Prior randomized trials found no significant improvement over standard care; more high-quality evidence is needed. | While established, lytic therapy is not universally effective and may require additional interventions; treatment choice depends on patient factors and infection severity. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 days
Participants receive twice daily fibrinolytic therapy through their chest tube. Those in the experimental group also receive daily saline irrigation through their chest tube until the pleural space is adequately evacuated as determined by their physician.
Daily visits for up to 3 days
Duration - Approximately 10 to 14 days
Participants are monitored for additional interventions, thoracostomy tube days, hospital stay duration, pain tolerance, and adverse events.
Regular visits during hospital stay up to 14 days
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Najib M Rahman, Nicholas A Maskell, Alex West...
https://pubmed.ncbi.nlm.nih.gov/21830966/Kate Birkenkamp, John C O'Horo, Rahul Kashyap...
https://pubmed.ncbi.nlm.nih.gov/26987740/Valentine Mismetti, Marios E Froudarakis
https://pubmed.ncbi.nlm.nih.gov/36173249/Eihab O Bedawi, Sara Ricciardi, Maged Hassan...
https://pubmed.ncbi.nlm.nih.gov/36229045/Clare E Hooper, Anthony J Edey, Anthony Wallis...
https://pubmed.ncbi.nlm.nih.gov/26022948/Mayo Clinic
Lead Sponsor