Closed-loop Control of Vasopressor Administration in Cardiac Surgery

Not Applicable

Completed

• Conditions: Hemodynamic MAP Stability
• Interventions: Device: closed-loop system for vasopressor administration

• Registration Number: NCT04232007
• Lead Sponsor: Erasme University Hospital

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.

Study Timeline

• Study Start: 2018-05-16
• Primary Completion: 2018-08-14
• Study Completion: 2018-08-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Last Update Submitted: 2020-01-15
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

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

Exclusion Criteria

• Atrial fibrillation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Closed-loop	closed-loop system for vasopressor administration	Closed-loop system to titrate vasopressor during surgery

Primary Outcome Measures

Name	Time	Method
percentage of time spent during surgery in hypotension	during surgery	percentage of time spent during surgery in hypotension defined as a MAP below 65 mmHg.

Secondary Outcome Measures

Name	Time	Method
time in target during surgery	during surgery	time with a MAP within 5 mmHg of the chosen target
Percentage of active treatment time spent in a hypertensive state	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
Amount of vasopressor used	during surgery	Amount of vasopressor administered to the patient

Trial Locations

Locations (1)

Erasme; 🇧🇪 Brussels, Anderlecht, Belgium