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The PRESSURE CABG Cardiac Surgery Trial (PRESSURECABG)

Primary Purpose

Coronary Artery Bypass Grafting, Hypotension

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Target MAP Management
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Bypass Grafting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Personalized Arm

Protocolized Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Re-operation for bleeding
re-operation for bleeding

Secondary Outcome Measures

Delirium
Incidence (defined as Intensive care delirium screening checklist score >=4) and duration of Delirium (in days)
The incidence of Stroke
post-operative stroke
Renal Outcomes
Risk of Acute kidney injury, Acute Kidney Injury, Renal Failure, Renal replacement therapy according to RIFLE criteria
Difference in peak median creatinine levels
Absolute difference in peak median creatinine levels
Chest tube output
Median differences in chest tube output
Blood Products
Number of red blood cell, fresh frozen plasma, and platelet transfusions
IV Vasoactive Support
Median duration of intravenous vasoactive support
Vasoactive support >24hrs
Percentage of patients with vasoactive support >24 hours
Mechanical Ventilation
Duration of mechanical ventilation
Length of Stay
Duration of CSICU stay

Full Information

First Posted
December 3, 2019
Last Updated
November 16, 2022
Sponsor
University of Alberta
Collaborators
Canadian VIGOUR Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04197700
Brief Title
The PRESSURE CABG Cardiac Surgery Trial
Acronym
PRESSURECABG
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Canadian VIGOUR Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Grafting, Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Pragmatic, prospective, single-center, unit-based cluster crossover, open-label registry
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized Arm
Arm Type
Other
Arm Description
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.
Arm Title
Protocolized Arm
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Target MAP Management
Intervention Description
Target MAP Management
Primary Outcome Measure Information:
Title
Composite of delirium or AKI
Description
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
Time Frame
within 7 days of surgery
Title
Re-operation for bleeding
Description
re-operation for bleeding
Time Frame
Within 7 days of surgery
Secondary Outcome Measure Information:
Title
Delirium
Description
Incidence (defined as Intensive care delirium screening checklist score >=4) and duration of Delirium (in days)
Time Frame
Through 7 days
Title
The incidence of Stroke
Description
post-operative stroke
Time Frame
Up to the time of hospital discharge, estimated average 5 days
Title
Renal Outcomes
Description
Risk of Acute kidney injury, Acute Kidney Injury, Renal Failure, Renal replacement therapy according to RIFLE criteria
Time Frame
Up to the time of hospital discharge, estimated average 5 days
Title
Difference in peak median creatinine levels
Description
Absolute difference in peak median creatinine levels
Time Frame
Up to the time of hospital discharge, estimated average 5 days
Title
Chest tube output
Description
Median differences in chest tube output
Time Frame
Through 48 hours post-op
Title
Blood Products
Description
Number of red blood cell, fresh frozen plasma, and platelet transfusions
Time Frame
Through 48 hours post-operatively
Title
IV Vasoactive Support
Description
Median duration of intravenous vasoactive support
Time Frame
Up to the time of ICU discharge, , estimated average 2 days
Title
Vasoactive support >24hrs
Description
Percentage of patients with vasoactive support >24 hours
Time Frame
Up to 25 hours post-operatively
Title
Mechanical Ventilation
Description
Duration of mechanical ventilation
Time Frame
Up to the time of ICU discharge, estimated average 4 hours
Title
Length of Stay
Description
Duration of CSICU stay
Time Frame
Up to the time of ICU discharge, estimated average 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean van Diepen, MD
Phone
780-407-6948
Email
sv9@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Kushniruk, RN, PhD
Phone
1-800-707-9098
Ext
7
Email
karin.kushniruk@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean van Diepen, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean van Diepen, MD
Phone
780-407-6948
Email
sv9@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Karin Kushniruk, RN, PhD
Phone
1-800-707-9098 Ext. 7
Email
karin.kushniruk@ualberta.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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The PRESSURE CABG Cardiac Surgery Trial

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