University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
NCT Number: NCT04197700
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Edmonton, Alberta, T6G 2B7, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Target MAP Management
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
Time frame: Within 7 days of surgery
re-operation for bleeding
Time frame: Through 7 days
Incidence (defined as Intensive care delirium screening checklist score >=4) and duration of Delirium (in days)
Time frame: Up to the time of hospital discharge, estimated average 5 days
post-operative stroke
Time frame: 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
Time frame: Up to the time of hospital discharge, estimated average 5 days
Absolute difference in peak median creatinine levels
Time frame: Through 48 hours post-op
Median differences in chest tube output
Time frame: Through 48 hours post-operatively
Number of red blood cell, fresh frozen plasma, and platelet transfusions
Time frame: Up to the time of ICU discharge, , estimated average 2 days
Median duration of intravenous vasoactive support
Time frame: Up to 25 hours post-operatively
Percentage of patients with vasoactive support >24 hours
Time frame: Up to the time of ICU discharge, estimated average 4 hours
Duration of mechanical ventilation
Time frame: Up to the time of ICU discharge, estimated average 2 days
Duration of CSICU stay
University of Alberta
Other
PRotocolized vs pErsonalized Blood preSSUre peRi-operative paramEters in Coronary Artery Bypass Grafting Surgery: The PRESSURE CABG Cardiac Surgery Trial
Acronym: PRESSURECABG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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