The PRESSURE CABG Cardiac Surgery Trial

NCT04197700 | Completed DMC

• 1 other identifier: Pro00095074
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass Grafting; Hypotension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Delirium

  Through 7 days

• The incidence of Stroke

  Up to the time of hospital discharge, estimated average 5 days

• Renal Outcomes

  Up to the time of hospital discharge, estimated average 5 days

• Difference in peak median creatinine levels

  Up to the time of hospital discharge, estimated average 5 days

• Chest tube output

  Through 48 hours post-op

Study Arms (2)

Personalized Arm

OTHER

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

Protocolized Arm

OTHER

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

Interventions

Target MAP Management OTHER

Target MAP Management

Personalized Arm; Protocolized Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients \> or = to 18 years of age undergoing non-emergent CABG

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Canadian VIGOUR Centre: collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sean van Diepen, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, prospective, single-center, unit-based cluster crossover, open-label registry

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 13, 2019
• Study Start: November 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)