The PRESSURE CABG Cardiac Surgery Trial
- Conditions
- HypotensionCoronary Artery Bypass Grafting
- Interventions
- Other: Target MAP Management
- Registration Number
- NCT04197700
- Lead Sponsor
- University of Alberta
- Brief Summary
This study will be a pragmatic, prospective, single-centre, unit-based cluster crossover, open-label registry trial. The cardiac surgical intensive care unit (CSICU) will be cluster assigned to alternating MAP targets in 6-month blocks in a sequence. Additional sites across Alberta may be added, as necessary.
- Detailed 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, 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 650
- All patients > or = to 18 years of age undergoing non-emergent CABG
- Pre-induction use of intravenous inotrope, vasopressor, or vasodilator
- Re-operation during the index hospital stay
- Non-CABG valvular or aortic surgery
- *Patients with end-stage renal disease or pre-operative AKI (defined as in-hospital increase in creatinine by >50%) will be excluded from the renal outcomes but included in the analysis of secondary outcomes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Personalized Arm Target MAP Management Personalized Arm: The target MAP will be defined as +/- 5% 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 order of the measurements prioritizes outpatient MAPs given that temporary pre-operative discontinuation of anti-hypertensive agents could potentially raise, while fasting and/or fluid restriction pre-operatively could potentially lower resting blood pressure.39 The lower and upper safety limits of personalized MAP targets will be 50mmHg and \<90mmHg, respectively. Protocolized Arm Target MAP Management 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.
- Primary Outcome Measures
Name Time Method Re-operation for bleeding Within 7 days of surgery re-operation for bleeding
Composite of delirium or AKI within 7 days of surgery composite of delirium(defined as Intensive care delirium screening checklist score \>=4) or Acute kidney injury (defined as a \>=50% rise in serum creatinine)m
- Secondary Outcome Measures
Name Time Method Delirium Through 7 days Incidence (defined as Intensive care delirium screening checklist score \>=4) and duration of Delirium (in days)
Difference in peak median creatinine levels Up to the time of hospital discharge, estimated average 5 days Absolute difference in peak median creatinine levels
IV Vasoactive Support Up to the time of ICU discharge, , estimated average 2 days Median duration of intravenous vasoactive support
Vasoactive support >24hrs Up to 25 hours post-operatively Percentage of patients with vasoactive support \>24 hours
Length of Stay Up to the time of ICU discharge, estimated average 2 days Duration of CSICU stay
Renal Outcomes Up to the time of hospital discharge, estimated average 5 days Risk of Acute kidney injury, Acute Kidney Injury, Renal Failure, Renal replacement therapy according to RIFLE criteria
Chest tube output Through 48 hours post-op Median differences in chest tube output
Blood Products Through 48 hours post-operatively Number of red blood cell, fresh frozen plasma, and platelet transfusions
Mechanical Ventilation Up to the time of ICU discharge, estimated average 4 hours Duration of mechanical ventilation
The incidence of Stroke Up to the time of hospital discharge, estimated average 5 days post-operative stroke
Trial Locations
- Locations (1)
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada