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Completed

NCT Number: NCT04197700

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Target MAP Management

Other

Target MAP Management

Primary outcomes

  1. Composite of delirium or AKI

    Time frame: within 7 days of surgery

    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

  2. Re-operation for bleeding

    Time frame: Within 7 days of surgery

    re-operation for bleeding

Secondary outcomes

  1. Delirium

    Time frame: Through 7 days

    Incidence (defined as Intensive care delirium screening checklist score >=4) and duration of Delirium (in days)

  2. The incidence of Stroke

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

    post-operative stroke

  3. Renal Outcomes

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

    Risk of Acute kidney injury, Acute Kidney Injury, Renal Failure, Renal replacement therapy according to RIFLE criteria

  4. Difference in peak median creatinine levels

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

    Absolute difference in peak median creatinine levels

  5. Chest tube output

    Time frame: Through 48 hours post-op

    Median differences in chest tube output

  6. Blood Products

    Time frame: Through 48 hours post-operatively

    Number of red blood cell, fresh frozen plasma, and platelet transfusions

  7. IV Vasoactive Support

    Time frame: Up to the time of ICU discharge, , estimated average 2 days

    Median duration of intravenous vasoactive support

  8. Vasoactive support >24hrs

    Time frame: Up to 25 hours post-operatively

    Percentage of patients with vasoactive support >24 hours

  9. Mechanical Ventilation

    Time frame: Up to the time of ICU discharge, estimated average 4 hours

    Duration of mechanical ventilation

  10. Length of Stay

    Time frame: Up to the time of ICU discharge, estimated average 2 days

    Duration of CSICU stay

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian VIGOUR Centre

Registry information

Official study title

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

Acronym: PRESSURECABG

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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