Erasme
Brussels, Anderlecht, 1070, Belgium
NCT Number: NCT04232007
Intraoperative hypotension and blood pressure variability are associated with postoperative complications in surgical patients.
The investigators have developed a closed-loop vasopressor (CLV) controller that titrates norepinephrine to correct hypotension.
After having tested the system in a small cohort series of patients undergoing major surgeries, the investigators aimed to test the feasibility of the CLV controller in three high risk patients undergoing cardiac surgery
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Brussels, Anderlecht, 1070, Belgium
The investigators have recently developed an automated closed-loop vasopressor (CLV) controller to better titrate vasopressor (e.g:norepinephrine) to maintain MAP within a narrow range (±5mmHg of the chosen target).
The investigators published engineering, animal studies and recently described the feasibility of titration of norepinephrine in 20 patients undergoing major noncardiac procedures. This initial cohort human study showed the controller was able to keep patients within ± 5 mmHg of a target pressure for more than 90% of management time. Cardiac surgery represents unique challenges in MAP management as the manipulation of the heart itself, the use of cardiopulmonary bypass (CPB) and cardioplegia, and the pre-existing cardiac disease all increase the difficulty in maintaining a steady MAP throughout the surgical period.
In this case series the investigators describe three cardiac surgical procedures managed with the CLV system (one coronary artery bypass graft (CABG) procedure done under CPB; one robotic minimally invasive direct coronary artery bypass (MIDCAB) procedure (through a mini-thoracotomy), and one off-pump CABG) in order to assess its feasibility, efficiency and behavior in three high-risk patients before starting a randomized controlled trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
closed-loop system for vasopressor administration
Time frame: during surgery
percentage of time spent during surgery in hypotension defined as a MAP below 65 mmHg.
Time frame: during surgery
time with a MAP within 5 mmHg of the chosen target
Time frame: during surgery
Percentage of active treatment time spent in a hypertensive state, defined as a MAP >5mmHg above the chosen target MAP with an active norepinephrine infusion
Time frame: during surgery
Amount of vasopressor administered to the patient
Erasme University Hospital
Other
Closed-loop Control of Vasopressor Administration in High-Risk Patients Undergoing Cardiac Surgery: A Case Series
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