Complicated Parapneumonic Effusion, Empyema, Pleural
Conditions
Brief 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.
Detailed 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 effusions fail to reduce by 75% or significant septations remain, the patient will then be escalated to intrapleural tPA/DNase which will be administered every 12 hours for 3 days. After the completed course of tPA/DNase, a US will be performed, and if significant fluid remains, \>50% of the original effusion or septations remain, Thoracic Surgery consultation will be placed for discussion of VATs.
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.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to chest tube removal | From enrollment to removal- estimated up to 7 days. Once chest tube is placed, it will take 3 days for saline course to be completed and, if escalated, 3 days for intrapleural fibrinolytics, therefore may not be removed until after 7 days. | measuring the length of time from chest tube insertion to removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for escalation to fibrinolytics | From enrollment to chest tube removal- up to 7 days. Once chest tube is placed, it will take 3 days for saline course to be completed and, if escalated, 3 days for intrapleural fibrinolytics, therefore may not be removed until after 7 days. | Rate of patients requiring intraplerual tPA/DNAse after completion of intrapleural saline |
| Need for escalation to Video-assisted thoracic surgery (VATS) | From enrollment to chest tube removal- up to 7 days. Once chest tube is placed, it will take 3 days for saline course to be completed and 3 days for intrapleural fibrinolytics, therefore VATs determined after, about 7 days. | Evaluation fo patients who require Video-assisted thoracic surgery (VATS) after completion of intraplerual saline and tPA/DNAse |
| Rate of hemothorax. | From enrollment to chest tube removal- up to 7 days. Once chest tube is placed, it will take 3 days for saline course to be completed and, if escalated, 3 days for intrapleural fibrinolytics, therefore may not be removed until after 7 days. | Evaluating number of patients who develop a hemothorax |
| Length of Hospital Stay | From enrollment to discharge- up to 52 weeks. | Quantifying the length of hospital stay for all patients enrolled |
| Mortality | 30 days from enrollment: rate of documented death prior or up to 30 days. | Rate of 30 day all cause mortally |
Countries
United States
Outcome results
None listed