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Closed-loop Control of Vasopressor Administration in Cardiac Surgery

Closed-loop Control of Vasopressor Administration in High-Risk Patients Undergoing Cardiac Surgery: A Case Series

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04232007
Enrollment
3
Registered
2020-01-18
Start date
2018-05-16
Completion date
2018-08-30
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic MAP Stability

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.

Interventions

closed-loop system for vasopressor administration

Sponsors

University of California, Los Angeles
CollaboratorOTHER
University of California, Irvine
CollaboratorOTHER
Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Closed-loop system to titrate vasopressor

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Atrial fibrillation

Design outcomes

Primary

MeasureTime frameDescription
percentage of time spent during surgery in hypotensionduring surgerypercentage of time spent during surgery in hypotension defined as a MAP below 65 mmHg.

Secondary

MeasureTime frameDescription
time in target during surgeryduring surgerytime with a MAP within 5 mmHg of the chosen target
Percentage of active treatment time spent in a hypertensive stateduring surgeryPercentage of active treatment time spent in a hypertensive state, defined as a MAP \>5mmHg above the chosen target MAP with an active norepinephrine infusion
Amount of vasopressor usedduring surgeryAmount of vasopressor administered to the patient

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026