Adding saline irrigation to standard treatment for pleural infections
A Study to Evaluate the Efficacy of Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in the Management of Empyema/Complicated Parapneumonic Effusion
This study is testing if adding saline irrigation through a chest tube to standard treatment can help people with pleural infections get better faster and spend less time in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06434324 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of saline irrigation through a chest tube in conjunction with standard intrapleural thrombolytic therapy for patients diagnosed with pleural space infections. The research focuses on improving pleural fluid evacuation and reducing hospital stays by potentially diluting bacteria and inflammatory factors in the pleural space. Patients will receive saline irrigation while undergoing standard antimicrobial therapy, and outcomes will be assessed based on clinical and radiographic improvements. The study is conducted at the Mayo Clinic, leveraging their expertise in interventional pulmonary care.
Who should consider this trial
Good fit: Ideal candidates include individuals with purulent pleural fluid or specific pleural fluid analysis results indicating infection, who are starting intrapleural lytic therapy.
Not a fit: Patients with bleeding disorders, high INR, or those currently on systemic anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and reduced need for surgical interventions in patients with pleural infections.
How similar studies have performed: Previous studies, such as the MIST 2 trial, have shown success with similar approaches in managing pleural space infections.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Purulent pleural fluid versus pleural fluid analysis demonstrating pH \<7.2, glucose \<60 mg/dL, positive Gram stain, or positive pleural fluid culture versus multiseptated pleural effusion with infection at top of differential diagnosis * Patients initiating intrapleural lytic therapy under the care of the Interventional Pulmonary consult service at Mayo Clinic in Rochester, MN Exclusion Criteria: * Unwillingness to give informed consent * Patients with known bleeding diathesis * Platelet count \<50,000 per μL * INR \>2.2 (of note, INR can be allowed to drift down or be reversed pharmacologically prior to initiation of intrapleural lytics/saline) * Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable) * Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment * Incarcerated patients * Presence of ipsilateral bronchopleural fistula * Current or recent (within past 30 days) presence of tunneled pleural catheter on the same side as the current proven/suspected pleural space infection
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Dagny Anderson, MD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.