Closed-loop Control of Vasopressor Administration in Cardiac Surgery

Hemodynamic MAP Stability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04232007
• Other study ID #: P2018(276)
• Status: Completed
• Phase: N/A
• Start date: May 16, 2018
• Est. completion date: August 30, 2018

Study information

• Verified date: January 2020
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 30, 2018
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Atrial fibrillation

Related Conditions & MeSH terms

• Hemodynamic MAP Stability

Intervention

Device:
• closed-loop system for vasopressor administration
closed-loop system for vasopressor administration

Locations

Country	Name	City	State
Belgium	Erasme	Brussels	Anderlecht

Sponsors (3)

Lead Sponsor	Collaborator
Erasme University Hospital	University of California, Irvine, University of California, Los Angeles

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of time spent during surgery in hypotension	percentage of time spent during surgery in hypotension defined as a MAP below 65 mmHg.	during surgery
Secondary	time in target during surgery	time with a MAP within 5 mmHg of the chosen target	during surgery
Secondary	Percentage of active treatment time spent in a hypertensive state	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	during surgery
Secondary	Amount of vasopressor used	Amount of vasopressor administered to the patient	during surgery