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Target MAP Management for Coronary Artery Bypass Surgery Patients (PRESSURECABG Trial)

Q: Is the trial actively enrolling volunteers at this time?

The details on clinicaltrials.gov show that this research endeavour is actively seeking patients; it was first advertised on the 1st of November 2022, with its most recent update being 16th of that same month.

Q: How many participants are being admitted into this clinical experiment?

Affirmative. According to the information found on clinicaltrials.gov, this medical trial is actively recruiting participants from a single site after first being posted on November 1st 2022. The data was last updated on November 16th and 650 patients are needed in total.

Q: What is the primary aim of this investigation?

This investigation measures a primary outcome, Re-operation for bleeding within seven days of surgery. Other secondary outcomes include the Median differences in chest tube output, post-operative <a href="https://www.withpower.com/clinical-trials/stroke">stroke</a> rates, and both incidence (defined as an Intensive Care Delirium Screening Checklist score >=4) and duration of delirium (in days).

N/A

Recruiting

Led By Sean van Diepen, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 48 hours post-op

Awards & highlights

PRESSURECABG Trial Summary

This trialwill compare two treatments in cardiac surgical ICUs in Alberta, Canada to see which is better.

Who is the study for?

This trial is for adults over 18 who are having non-emergency coronary artery bypass graft (CABG) surgery. It's not for those who've used certain heart drugs before surgery, had a re-operation during their hospital stay, need other types of heart valve or aortic surgeries, or have severe kidney issues.Check my eligibility

What is being tested?

The study tests different blood pressure targets after CABG surgery to see which is better. Patients in the cardiac surgical ICU will be treated with alternating blood pressure goals every six months to compare outcomes.See study design

What are the potential side effects?

Since this trial involves managing blood pressure targets rather than testing new medications, side effects may relate more to the risks associated with low or high blood pressure management post-surgery.

PRESSURECABG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older and scheduled for a non-emergency heart bypass surgery.

PRESSURECABG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 48 hours post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 48 hours post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 48 hours post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite of delirium or AKI

Re-operation for bleeding

Secondary outcome measures

Blood Products

Chest tube output

Delirium

+7 more

PRESSURECABG Trial Design

2Treatment groups

Experimental Treatment

Group I: Protocolized ArmExperimental Treatment1 Intervention

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.

Group II: Personalized ArmExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian VIGOUR CentreOTHER

8 Previous Clinical Trials

10,398 Total Patients Enrolled

University of AlbertaLead Sponsor

889 Previous Clinical Trials

384,527 Total Patients Enrolled

Sean van Diepen, MDPrincipal InvestigatorUniversity of Alberta

2 Previous Clinical Trials

8,560 Total Patients Enrolled

Media Library

Target MAP Management (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04197700 — N/A

Coronary Artery Bypass Surgery Research Study Groups: Protocolized Arm, Personalized Arm

Coronary Artery Bypass Surgery Clinical Trial 2023: Target MAP Management Highlights & Side Effects. Trial Name: NCT04197700 — N/A

Target MAP Management (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04197700 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial actively enrolling volunteers at this time?

"The details on clinicaltrials.gov show that this research endeavour is actively seeking patients; it was first advertised on the 1st of November 2022, with its most recent update being 16th of that same month."

Answered by AI

How many participants are being admitted into this clinical experiment?

"Affirmative. According to the information found on clinicaltrials.gov, this medical trial is actively recruiting participants from a single site after first being posted on November 1st 2022. The data was last updated on November 16th and 650 patients are needed in total."

Answered by AI

What is the primary aim of this investigation?

"This investigation measures a primary outcome, Re-operation for bleeding within seven days of surgery. Other secondary outcomes include the Median differences in chest tube output, post-operative stroke rates, and both incidence (defined as an Intensive Care Delirium Screening Checklist score >=4) and duration of delirium (in days)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The PRESSURE CABG Cardiac Surgery Trial

2022. "The PRESSURE CABG Cardiac Surgery Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04197700.