Coronary Artery Bypass GraftingPRESSURECABGNCT04197700
The PRESSURE CABG Cardiac Surgery Trial
A study testing Target MAP Management in people with Coronary Artery Bypass Grafting and Hypotension, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting, Hypotension
- What is being tested?
- Target MAP Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2022to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients > or = to 18 years of age undergoing non-emergent CABG
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Bypass Grafting, Hypotension
- Being tested
- Target MAP Management
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target MAP ManagementOther
Target MAP Management
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Target MAP Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 7 days of surgery
Re-operation for bleeding
re-operation for bleeding
Measured: Within 7 days of surgery
Secondary outcomes (10)
Delirium
Incidence (defined as Intensive care delirium screening checklist score >=4) and duration of Delirium (in days)
Measured: Through 7 days
The incidence of Stroke
post-operative stroke
Measured: 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
Measured: Up to the time of hospital discharge, estimated average 5 days
Difference in peak median creatinine levels
Absolute difference in peak median creatinine levels
Measured: Up to the time of hospital discharge, estimated average 5 days
Chest tube output
Median differences in chest tube output
Measured: Through 48 hours post-op
Blood Products
Number of red blood cell, fresh frozen plasma, and platelet transfusions
Measured: Through 48 hours post-operatively
IV Vasoactive Support
Median duration of intravenous vasoactive support
Measured: Up to the time of ICU discharge, , estimated average 2 days
Vasoactive support >24hrs
Percentage of patients with vasoactive support >24 hours
Measured: Up to 25 hours post-operatively
Mechanical Ventilation
Duration of mechanical ventilation
Measured: Up to the time of ICU discharge, estimated average 4 hours
Length of Stay
Duration of CSICU stay
Measured: Up to the time of ICU discharge, estimated average 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Nov 2022
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Pragmatic, prospective, single-center, unit-based cluster crossover, open-label registry
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian VIGOUR Centre
- Responsible party
- Sponsor
- Investigators
- Sean van Diepen, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197700
- Sponsor's protocol ID
- Pro00095074
- Acronym
- PRESSURECABG
- Status last verified
- Sep 2024
- First submitted
- 3 Dec 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRotocolized vs pErsonalized Blood preSSUre peRi-operative paramEters in Coronary Artery Bypass Grafting Surgery: The PRESSURE CABG Cardiac Surgery Trial
- ClinicalTrials.gov ID
- NCT04197700
- Acronym / sponsor ID
- PRESSURECABG / Pro00095074
- Conditions
- Coronary Artery Bypass Grafting, Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian VIGOUR Centre
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic, prospective, single-center, unit-based cluster crossover, open-label registry
| Arm | Type | Receives |
|---|---|---|
| Personalized Arm | Other | Other: Target MAP ManagementPersonalized 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 | Other | Other: Target MAP ManagementProtocolized 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients > or = to 18 years of age undergoing non-emergent CABG
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target MAP ManagementTarget MAP Management | Other | Personalized Arm, Protocolized Arm |
Primary outcome
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
Re-operation for bleeding
Time frame: Within 7 days of surgery
re-operation for bleeding
10 secondary outcomes
Delirium
Time frame: Through 7 days
The incidence of Stroke
Time frame: Up to the time of hospital discharge, estimated average 5 days
Renal Outcomes
Time frame: Up to the time of hospital discharge, estimated average 5 days
Difference in peak median creatinine levels
Time frame: Up to the time of hospital discharge, estimated average 5 days
Chest tube output
Time frame: Through 48 hours post-op
Blood Products
Time frame: Through 48 hours post-operatively
IV Vasoactive Support
Time frame: Up to the time of ICU discharge, , estimated average 2 days
Vasoactive support >24hrs
Time frame: Up to 25 hours post-operatively
Mechanical Ventilation
Time frame: Up to the time of ICU discharge, estimated average 4 hours
Length of Stay
Time frame: Up to the time of ICU discharge, estimated average 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Recruiting
CCTA-Based vs CAG-Based CABG: A Multicenter Pragmatic Non-Inferiority Trial
Coronary Artery Disease, Coronary Artery Bypass Grafting
Recruiting
Fasciotomy and Predilation for Radial Artery Grafts in CABG
Coronary Artery Bypass, Radial Artery Grafts
RecruitingPhase 3
Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)
Chronic Coronary Syndrome, Stable Coronary Artery Disease CAD
Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Prehabilitation, Cardiac Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean van Diepen, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target MAP Management in people with Coronary Artery Bypass Grafting and Hypotension, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of delirium or AKI (time frame: within 7 days of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.