The PRESSURE CABG Cardiac Surgery Trial (PRESSURECABG)

University of Alberta

Status: Completed

Conditions: Hypotension; Coronary Artery Bypass Grafting

Treatments: Other: Target MAP Management

Study type: Interventional

Funder types: Other

Identifiers

NCT04197700

Pro00095074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Personalized Arm

Other group

Description:

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.

Treatment:

Other: Target MAP Management

Protocolized Arm

Other group

Description:

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.

Treatment:

Other: Target MAP Management