Closed-loop Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring

Feasibility of Computer-assisted Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring in High-risk Patients Undergoing Renal Transplant 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 guided noninvasively and continuously with the ClearSight system (Edwards Lifesciences, USA) in three high risk patients undergoing renal transplant surgery

Study Overview

• Status: Completed
• Conditions: Hemodynamic (MAP) Stability
• Intervention / Treatment: Device: Closed-loop system

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)

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Closed-loop group; 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.	Device: Closed-loop system; the CLV system will correct hypotension by automated adjustment of norepinephrine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of case time in hypotension	% of case time without hypotension. MAP of at least 5mmHg below the chosen CLV target	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Amount of vasopressor used	Amount of vasopressor administered to the patient	during surgery
Incidence of acute kidney injury	Incidence of acute kidney injury defined with the KDIGO classification	30 days postsurgery

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Collaborators: University of California, Los Angeles; University of California, Irvine

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2018
• Primary Completion (ACTUAL): July 20, 2018
• Study Completion (ACTUAL): July 20, 2018

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: September 29, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: P2018-276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No