Coronary Artery Bypass Grafting, Hypotension
Conditions
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.
Interventions
OTHERTarget MAP Management
Target MAP Management
Sponsors
Canadian VIGOUR Centre
University of Alberta
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pragmatic, prospective, single-center, unit-based cluster crossover, open-label registry
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of delirium or AKI | 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 | Within 7 days of surgery | re-operation for bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal Outcomes | 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 |
| Difference in peak median creatinine levels | Up to the time of hospital discharge, estimated average 5 days | Absolute difference in peak median creatinine levels |
| Chest tube output | Through 48 hours post-op | Median differences in chest tube output |
| Blood Products | Through 48 hours post-operatively | Number of red blood cell, fresh frozen plasma, and platelet transfusions |
| Delirium | Through 7 days | Incidence (defined as Intensive care delirium screening checklist score \>=4) and duration of Delirium (in days) |
| Vasoactive support >24hrs | Up to 25 hours post-operatively | Percentage of patients with vasoactive support \>24 hours |
| Mechanical Ventilation | Up to the time of ICU discharge, estimated average 4 hours | Duration of mechanical ventilation |
| Length of Stay | Up to the time of ICU discharge, estimated average 2 days | Duration of CSICU stay |
| IV Vasoactive Support | Up to the time of ICU discharge, , estimated average 2 days | Median duration of intravenous vasoactive support |
| The incidence of Stroke | Up to the time of hospital discharge, estimated average 5 days | post-operative stroke |
Countries
Canada
Outcome results
None listed