Pulmonary Artery Catheters in Cardiac Surgery
ConditionCardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMonash University
About this trial
The goal of this clinical trial is to learn whether avoiding a pulmonary artery catheter (PAC), a type of invasive monitoring tool, is no worse than using one in adults undergoing open heart surgery.
The main questions it will answer are:
1. Does avoiding routine PAC use lead to recovery that is no worse than routine PAC use, measured by days alive and at home during the first 30 days after surgery? 2. How do the 2 strategies compare for kidney injury, major complications, survival, disability-free survival, quality of life, and healthcare use?
Researchers will compare routine PAC use with no routine PAC use (using a standard central venous catheter instead) to see whether patients recover as well without a PAC.
Participants will:
Be randomly assigned to have either a PAC or no PAC at the start of their surgery Receive usual care from their treating team Be followed up at about 30 days and 180 days after surgery, mainly by telephone and review of medical records
No extra in-person study visits or additional tests are required as part of this trial.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Undergoing cardiac surgery or surgery of the thoracic aorta
Disqualifiers
Predicted operative mortality ≥ 3% based on the EuroSCORE II
Emergency surgery, defined as surgery that must be performed within 24 hours of the decision to operate or before the start of the next business day, whichever is sooner
Severe left ventricular systolic impairment (ejection fraction <30%)
Mean pulmonary artery pressure (mPAP) ≥ 20 mmHg based on the most recent formal right heart catheterisation (RHC) study conducted pre-operatively; else, if no RHC performed
Trial design
Treatments tested in this trial
- Pulmonary Artery Catheter
- No Pulmonary Artery Catheter (No-PAC)
Treatment groups
1,600 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Monash University
Lead sponsor
Medical Research Future Fund
Collaborator
National Heart Foundation, Australia
Collaborator
Source ClinicalTrials.gov