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Completed

NCT Number: NCT04232007

Closed-loop Control of Vasopressor Administration in Cardiac Surgery

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme

Brussels, Anderlecht, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Atrial fibrillation

Treatment and study plan

closed-loop system for vasopressor administration

Device

closed-loop system for vasopressor administration

Primary outcomes

  1. percentage of time spent during surgery in hypotension

    Time frame: during surgery

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

Secondary outcomes

  1. time in target during surgery

    Time frame: during surgery

    time with a MAP within 5 mmHg of the chosen target

  2. Percentage of active treatment time spent in a hypertensive state

    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

  3. Amount of vasopressor used

    Time frame: during surgery

    Amount of vasopressor administered to the patient

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Collaborators

  • University of California, Irvine
  • University of California, Los Angeles

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2020
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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