Flush, Lyse, Operate
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18+
Complicated Parapneumonic Effusion or Empyema Requiring Thoracostomy
Are able to personally or have a designated medical decision maker provide consent
Disqualifiers
Age < 18 years
Have received any intrapleural medications prior to enrolment via current chest tube
Anticoagulation
Active hemorrhage
Trial design
Design model
Single group
Treatments tested in this trial
Intrapleural Saline with possible escalation to intraplerual alteplase and dornase.
DrugThough 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Intraplerual SalineOther 1 intervention
Trial outcomes
Primary outcomes
1
Time to chest tube removal
measuring the length of time from chest tube insertion to removal
Time frame
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.Secondary outcomes
1
Need for escalation to fibrinolytics
Rate of patients requiring intraplerual tPA/DNAse after completion of intrapleural saline
Time frame
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.2
Need for escalation to Video-assisted thoracic surgery (VATS)
Evaluation fo patients who require Video-assisted thoracic surgery (VATS) after completion of intraplerual saline and tPA/DNAse
Time frame
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.3
Rate of hemothorax.
Evaluating number of patients who develop a hemothorax
Time frame
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.4
Length of Hospital Stay
Quantifying the length of hospital stay for all patients enrolled
Time frame
From enrollment to discharge- up to 52 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: