Clinical trial NCT04111055: Closed-loop Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring
Official title: Feasibility of Computer-assisted Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring in High-risk Patients Undergoing Renal Transplant Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic (MAP) Stability
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of California, Irvine
First posted: 2019-10-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single prospective pilot study
Primary purpose: TREATMENT

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

Detailed 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)

Eligibility criteria: 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%

Primary outcomes:
measure: Percentage of case time in hypotension
timeFrame: during surgery
Secondary outcomes:
measure: Percentage of active treatment time spent in a hypertensive state
timeFrame: during surgery
measure: Amount of vasopressor used
timeFrame: during surgery
measure: Incidence of acute kidney injury
timeFrame: 30 days postsurgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme
Study officials:
affiliation: ERASME
name: Alexandre J Joosten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: