Closed-loop Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring

Free University of Brussels (ULB)

Status: Completed

Conditions: Hemodynamic (MAP) Stability

Treatments: Device: Closed-loop system

Study type: Interventional

Funder types: Other

Identifiers

NCT04111055

P2018-276

Details and patient eligibility

About

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 guided noninvasively and continuously with the ClearSight system (Edwards Lifesciences, USA) in three high risk patients undergoing renal transplant surgery

Full description

Intraoperative hypotension is frequent in patients undergoing surgery and can negatively impact organ perfusion.

The investigators have developed a closed-loop vasopressor (CLV) controller to more efficiently correct hypotension.

The investigators tested it extensively in preclinical studies and recently demonstrated its feasibility and excellent performance metrics in a short series of high-risk patients undergoing major surgical procedures.

In these studies, the controller was linked to a minimally-invasive advanced hemodynamic monitoring device utilizing an arterial line which then controlled a vasopressor infusion. However, the vast majority of patients who undergo surgery do not require an arterial line but should still benefit from rapid corrections of hypotensive episodes that are less rapidly detected via an intermittent non-invasive blood pressure cuff. Fortunately, completely noninvasive technology now allows us to continuously monitor blood pressure and therefore extend the use of our closed-loop vasopressor system to patients in whom an arterial catheter would not typically be placed. Patients undergoing renal transplant surgeries are the ideal patient population.

The investigators aimed to test the feasibility of guiding our CLV controller with a continuous noninvasive blood pressure monitoring device (ClearSight system, Edwards Lifesciences, Irvine, CA, USA) in three patients (case series)

Enrollment: 3 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult high risk patients undergoing renal transplant surgery
2. Patients equipped with a clearsight advanced hemodynamic monitoring system

Exclusion criteria

1. Atrial fibrillation
2. No consent obtained from the patient.
3. Ejection fraction < 30%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Closed-loop group

Experimental group

Description:

The MAP of the patient will be managed by the CLV system to avoid hypotension. The MAP target selected in the closed-loop system will be the patient's MAP target ( same target as patient's MAP value preoperatively). Then the closed-loop system will have to adjust norepinephrine infusion rate to keep that MAP value within 10% of patient's target.

Treatment:

Device: Closed-loop system