The PRESSURE CABG Cardiac Surgery Trial (PRESSURECABG)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypotension; Coronary Artery Bypass Grafting
• Intervention / Treatment: Other: Target MAP Management

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 Type: Interventional
• Enrollment (Estimated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sean van Diepen, MD; Phone Number: 780-407-6948; Email: sv9@ualberta.ca
• Study Contact Backup: Name: Karin Kushniruk, RN, PhD; Phone Number: 7 1-800-707-9098; Email: karin.kushniruk@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Recruiting
      • University of Alberta Hospital
      • Contact: Sean van Diepen, MD; Phone Number: 780-407-6948; Email: sv9@ualberta.ca
      • Contact: Karin Kushniruk, RN, PhD; Phone Number: 1-800-707-9098 Ext. 7; Email: karin.kushniruk@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: Target MAP Management; 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.	Other: Target MAP Management; Target MAP Management

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Canadian VIGOUR Centre
• Investigators: Principal Investigator: Sean van Diepen, MD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: Pro00095074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No