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The PRESSURE CABG Cardiac Surgery Trial

The PRESSURE CABG Cardiac Surgery Trial

Non Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

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 details
    Coronary Artery Bypass Grafting
    Hypotension

NCT04197700

University of Alberta

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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