The PRESSURE CABG Cardiac Surgery Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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PRotocolized vs pErsonalized Blood preSSUre peRi-operative paramEters in Coronary Artery Bypass Grafting Surgery: The PRESSURE CABG Cardiac Surgery Trial

Conditions
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Coronary Artery Bypass Grafting, Hypotension

Intervention / Treatment
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* Other: Target MAP Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Pragmatic, prospective, single-center, unit-based cluster crossover, open-label registry
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Personalized Arm<br>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. | Other: Target MAP Management<br>* Target MAP Management<br>|
| Other: Protocolized Arm<br>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. | Other: Target MAP Management<br>* Target MAP Management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of delirium or AKI | 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 | within 7 days of surgery | 
| Re-operation for bleeding | re-operation for bleeding | Within 7 days of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium | Incidence (defined as Intensive care delirium screening checklist score >=4) and duration of Delirium (in days) | Through 7 days | 
| The incidence of Stroke | post-operative stroke | Up to the time of hospital discharge, estimated average 5 days | 
| Renal Outcomes | Risk of Acute kidney injury, Acute Kidney Injury, Renal Failure, Renal replacement therapy according to RIFLE criteria | Up to the time of hospital discharge, estimated average 5 days | 
| Difference in peak median creatinine levels | Absolute difference in peak median creatinine levels | Up to the time of hospital discharge, estimated average 5 days | 
| Chest tube output | Median differences in chest tube output | Through 48 hours post-op | 
| Blood Products | Number of red blood cell, fresh frozen plasma, and platelet transfusions | Through 48 hours post-operatively | 
| IV Vasoactive Support | Median duration of intravenous vasoactive support | Up to the time of ICU discharge, , estimated average 2 days | 
| Vasoactive support >24hrs | Percentage of patients with vasoactive support >24 hours | Up to 25 hours post-operatively | 
| Mechanical Ventilation | Duration of mechanical ventilation | Up to the time of ICU discharge, estimated average 4 hours | 
| Length of Stay | Duration of CSICU stay | Up to the time of ICU discharge, estimated average 2 days |