The goal of this clinical trial is to find out if giving certain medications once a day works just as well as giving them twice a day to treat infections around the lungs (called pleural infections). These medications-tissue plasminogen activator (tPA) and deoxyribonuclease (DNase)-are placed through a chest tube into the space between the lung and the chest wall to help clear out the infection.
The investigators are trying to learn:
* Does using the medicine once a day work just as well as using it twice a day? * Are there any differences in outcomes between patients who get the medicine once a day versus twice a day? * Does more or less fluid remain in the chest (seen on a chest x-ray) depending on how often the medicine is given?
Participants will:
* Have an infection around their lung and will already be getting normal hospital care, including a chest tube to drain the infected fluid around their lung. * Be asked to give permission to join the study. * Be randomly chosen (like flipping a coin) to get the medications either once a day or twice a day through the chest tube.
Written informed consent obtained from patient or patient's legally authorized representative (LAR) to participate in the study and HIPAA authorization for release of personal health information.
Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
Age ≥ 18 years at the time of consent.
Patient is admitted to the hospital and with a pleural effusion that is drained with a small-bore chest tube or one that allows for administration of IET
Known pregnancy or lactating females
Prisoners
Age <18 years at time of consent
Previous treatment with intra-pleural fibrinolytic agents, DNase, or both during the same hospital admission
Parallel
Fibrinolytic once daily
Drugtissue plasminogen activator (tPA) 10mg will be administered once a day as part of intrapleural enzyme therapy (IET) for 3 consecutive days.
Fibrinolytic twice daily
Drugtissue plasminogen activator (tPA) 10mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.
DNA degradation once daily
DrugDeoxyribonuclease (DNase) 5mg will be administered once a day as intrapleural enzyme therapy (IET) for 3 consecutive days.
DNA degradation twice daily
DrugDeoxyribonuclease (DNase) 5mg will be administered twice a day as intrapleural enzyme therapy for 3 consecutive days.
IET Failure: Surgery and/or mortality at 90 days
Measure the rate of IET failure (defined as surgery and/or mortality at 90 days) in both once daily IET and twice daily IET groups.
30 Day Mortality
Evaluate rate of mortality at 30 days between the participants receiving once daily IET and twice daily IET
Hospital length of stay
Evaluate length of hospitalization stay between the participants receiving once daily IET and twice daily IET
Oral Morphine Equivalents (OME)
Evaluate the difference in amount of oral morphine equivalents, which is a standardized method of reporting narcotic analgesic administration by converting opioid narcotics as determined by morphine milligram equivalents (MME) that would yield same result, for daily pain between once daily IET and twice daily IET.
Change of White Blood Cell Count
Evaluate the difference between white blood cell (WBC) count in units of cells per microliter (cells/μL) between once daily IET and twice daily IET.
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
Northwestern Memorial Hospital
Collaborator
Henry Ford Health System
Collaborator
Yale University
Collaborator
Rush University Medical Center
Collaborator
Dartmouth-Hitchcock Medical Center
Collaborator
