The PRESSURE CABG Cardiac Surgery Trial

Hypotension Clinical Trial

— PRESSURECABG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04197700
• Other study ID #: Pro00095074
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: University of Alberta
• Contact: Sean van Diepen, MD
• Phone: 780-407-6948
• Email: sv9[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: December 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting
• Hypotension

Intervention

Other:
• Target MAP Management
Target MAP Management

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian VIGOUR Centre

Country where clinical trial is conducted

Canada, 

Outcome

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