NCT04111055

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Hemodynamic (MAP) Stability

Interventions

Type	Name	Description
DEVICE	Closed-loop system	the CLV system will correct hypotension by automated adjustment of norepinephrine.

Timeline

• Start date: 2018-06-15
• Primary completion: 2018-07-20
• Completion: 2018-07-20
• First posted: 2019-10-01
• Last updated: 2019-11-18

Locations

1 site across 1 country: Belgium