Flush, Lyse, Operate
NCT07592520 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-18
Summary
The goal of this observational study is to learn if saline results in improvement for patients with infection of their plerual space. The main question it aims to answer is:
What is the time to chest tube removal? Do these patients after need to escalate to fibrinolytics? Do these patients after need to escalate to surgery?
Participants will:
* Receive receive saline into their pleural space through an existing chest tube
* If they fail to improve, which will be determined by fluid size after treatment or signs of persistent infection, they will receive fibrynolytics through an existing chest tube
* If they fail to improve, which will be determined by fluid size after treatment or signs of persistent infection, they will be referred to surgery.
Conditions
- Complicated Parapneumonic Effusion
- Empyema, Pleural
Interventions
- DRUG
-
Intrapleural Saline with possible escalation to intraplerual alteplase and dornase.
Though intraplerual alteplase/ dornase alfa and normal saline have been established method to reduce complicated pleural infection sizes and rate of surgical interventions, with tPA/DNAse being the gold standards, there has not been a study comparing the two head to head. This trial's purpose is to function as pilot study as a foundation for a potential noninferiorrity trail comparing the two.
Sponsors & Collaborators
-
Dartmouth-Hitchcock Medical Center
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2027-04-30
- Completion
- 2027-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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