PRotocolized vs pErsonalized Blood preSSUre peRi-operative paramEters in Coronary Artery Bypass Grafting Surgery: The PRESSURE CABG Cardiac Surgery Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alberta
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Composite of delirium or AKI
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients > or = to 18 years of age undergoing non-emergent CABG
Exclusion Criteria
- •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
Arms & Interventions
Personalized Arm
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.
Intervention: Target MAP Management (Other)
Protocolized Arm
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.
Intervention: Target MAP Management (Other)
Outcomes
Primary Outcomes
Composite of delirium or AKI
Time Frame: 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
Re-operation for bleeding
Time Frame: Within 7 days of surgery
re-operation for bleeding
Secondary Outcomes
- Difference in peak median creatinine levels(Up to the time of hospital discharge, estimated average 5 days)
- IV Vasoactive Support(Up to the time of ICU discharge, , estimated average 2 days)
- Vasoactive support >24hrs(Up to 25 hours post-operatively)
- Length of Stay(Up to the time of ICU discharge, estimated average 2 days)
- Delirium(Through 7 days)
- Renal Outcomes(Up to the time of hospital discharge, estimated average 5 days)
- Chest tube output(Through 48 hours post-op)
- Blood Products(Through 48 hours post-operatively)
- Mechanical Ventilation(Up to the time of ICU discharge, estimated average 4 hours)
- The incidence of Stroke(Up to the time of hospital discharge, estimated average 5 days)