Clinical trial NCT04197700: The PRESSURE CABG Cardiac Surgery Trial
Official title: PRotocolized vs pErsonalized Blood preSSUre peRi-operative paramEters in Coronary Artery Bypass Grafting Surgery: The PRESSURE CABG Cardiac Surgery Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Grafting
Hypotension
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian VIGOUR Centre
First posted: 2019-12-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pragmatic, prospective, single-center, unit-based cluster crossover, open-label registry
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of delirium or AKI
timeFrame: within 7 days of surgery
measure: Re-operation for bleeding
timeFrame: Within 7 days of surgery
Secondary outcomes:
measure: Delirium
timeFrame: Through 7 days
measure: The incidence of Stroke
timeFrame: Up to the time of hospital discharge, estimated average 5 days
measure: Renal Outcomes
timeFrame: Up to the time of hospital discharge, estimated average 5 days
measure: Difference in peak median creatinine levels
timeFrame: Up to the time of hospital discharge, estimated average 5 days
measure: Chest tube output
timeFrame: Through 48 hours post-op
measure: Blood Products
timeFrame: Through 48 hours post-operatively
measure: IV Vasoactive Support
timeFrame: Up to the time of ICU discharge, , estimated average 2 days
measure: Vasoactive support >24hrs
timeFrame: Up to 25 hours post-operatively
measure: Mechanical Ventilation
timeFrame: Up to the time of ICU discharge, estimated average 4 hours
measure: Length of Stay
timeFrame: Up to the time of ICU discharge, estimated average 2 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sean van Diepen, MD
role: PRINCIPAL_INVESTIGATOR
References: