The PRESSURE CABG Cardiac Surgery Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronary Artery Bypass Grafting
- Hypotension
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Pragmatic, prospective, single-center, unit-based cluster crossover, open-label registryMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Personalized Arm: The target MAP will be defined as +10% of the resting MAP. Resting MAP will be defined in priority order using one of the following MAP measurements: Pre-operative anesthesia or surgical consultation; Other physician outpatient consultation (e.g. cardiology, family physician, inter...
Personalized Arm: The target MAP will be defined as +10% of the resting MAP. Resting MAP will be defined in priority order using one of the following MAP measurements: Pre-operative anesthesia or surgical consultation; Other physician outpatient consultation (e.g. cardiology, family physician, internist) within 30 days of surgery; Inpatient measurement the night before surgery; Pre-anesthetic MAP The lower and upper safety limits of personalized MAP targets will be 50mmHg and <90mmHg, respectively. Protocolized Arm: The target MAP will be defined as 65 +/- 5mmHg. Pharmacologic and fluid treatment decisions will be at the discretion of the most responsible physician. In both study arms, the blood pressure control period will extend from anesthetic induction until 12 hours after admission to the CSICU. As an additional safety metric, the anesthesiologist will be encouraged to utilize clinically-driven cerebral saturation monitoring to identify potential hypoperfusion. In cases with low bilateral saturations where the anesthesiologist feels low MAP may be the putative mechanism, the investigators will request that MAPs be raised in 5mmHg increments. Following completion of the study protocol, the MAP and/or systolic blood pressure targets will be at the discretion of the most responsible physician.
Tracking Information
- NCT #
- NCT04197700
- Collaborators
- Canadian VIGOUR Centre
- Investigators
- Principal Investigator: Sean van Diepen, MD University of Alberta