Flush, Lyse, Operate: A Pilot Trial of Step-Wise Escalation for Pleural Infection: FLO Trial
Dartmouth-Hitchcock Medical Center
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.
Description
Patients who require a chest tube for complicated parapneumonic effusion or empyema who meet inclusion criteria and consent, will be enrolled. An ultrasound measurement of the original effusions prior to chest tube placement will be obtained then chest tube insertion will follow as well as an additional US measurement once placed. After appropriate positioning is confirmed, there will be instillation of intrapleural saline and will be administered every 8 hours for a total of 3 days. After completion of the intrapleural saline course, the effusion will be remeasured by ultrasound. Should the e…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18+ * Complicated Parapneumonic Effusion or Empyema Requiring Thoracostomy * Are able to personally or have a designated medical decision maker provide consent Exclusion Criteria: * Age \< 18 years * Have received any intrapleural medications prior to enrolment via current chest tube * Have a contraindication to tPA/DNase: * Anticoagulation * Active hemorrhage * Allergy to tPA/DNase * Pregnancy * Are unable to personally or do not have a designated medical decision maker provide consent
Interventions
- DrugIntrapleural 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.
Location
- Dartmouth-Hitchcock Medical CenterHanover, New Hampshire