Clinical trial NCT04232007: Closed-loop Control of Vasopressor Administration in Cardiac Surgery
Official title: Closed-loop Control of Vasopressor Administration in High-Risk Patients Undergoing Cardiac Surgery: A Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic MAP Stability
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of California, Irvine
First posted: 2020-01-18
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Closed-loop system to titrate vasopressor
Primary purpose: OTHER

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult high risk patients undergoing cardiac surgery (robotic, off-pump and on pump cardiac surgery)

Exclusion Criteria:

* Atrial fibrillation

Primary outcomes:
measure: percentage of time spent during surgery in hypotension
timeFrame: during surgery
Secondary outcomes:
measure: time in target during surgery
timeFrame: during surgery
measure: Percentage of active treatment time spent in a hypertensive state
timeFrame: during surgery
measure: Amount of vasopressor used
timeFrame: during surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme
state: Anderlecht
Study officials:
affiliation: ERASME
name: Alexandre Joosten
role: PRINCIPAL_INVESTIGATOR
References: