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| Name | Class |
|---|---|
| Canadian VIGOUR Centre | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Target MAP Management | Other | Target MAP Management |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Re-operation for bleeding | re-operation for bleeding | Within 7 days of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium | Incidence (defined as Intensive care delirium screening checklist score >=4) and duration of Delirium (in days) | Through 7 days |
| The incidence of Stroke | post-operative stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean van Diepen, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Pragmatic, prospective, single-center, unit-based cluster crossover, open-label registry
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| 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 | Up to the time of hospital discharge, estimated average 5 days |
| Difference in peak median creatinine levels | Absolute difference in peak median creatinine levels | Up to the time of hospital discharge, estimated average 5 days |
| Chest tube output | Median differences in chest tube output | Through 48 hours post-op |
| Blood Products | Number of red blood cell, fresh frozen plasma, and platelet transfusions | Through 48 hours post-operatively |
| IV Vasoactive Support | Median duration of intravenous vasoactive support | Up to the time of ICU discharge, , estimated average 2 days |
| Vasoactive support >24hrs | Percentage of patients with vasoactive support >24 hours | Up to 25 hours post-operatively |
| Mechanical Ventilation | Duration of mechanical ventilation | Up to the time of ICU discharge, estimated average 4 hours |
| Length of Stay | Duration of CSICU stay | Up to the time of ICU discharge, estimated average 2 days |