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Clinical Trials/NCT04111055
NCT04111055
Completed
N/A

Feasibility of Computer-assisted Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring in High-risk Patients Undergoing Renal Transplant Surgery

Erasme University Hospital1 site in 1 country3 target enrollmentJune 15, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hemodynamic (MAP) Stability
Sponsor
Erasme University Hospital
Enrollment
3
Locations
1
Primary Endpoint
Percentage of case time in hypotension
Status
Completed
Last Updated
6 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
June 15, 2018
End Date
July 20, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Erasme University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Alexandre Joosten, MD PhD

Principal Investigator

Erasme University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Atrial fibrillation
  • No consent obtained from the patient.
  • Ejection fraction \< 30%

Outcomes

Primary Outcomes

Percentage of case time in hypotension

Time Frame: during surgery

% of case time without hypotension. MAP of at least 5mmHg below the chosen CLV target

Secondary Outcomes

  • Incidence of acute kidney injury(30 days postsurgery)
  • Amount of vasopressor used(during surgery)
  • Percentage of active treatment time spent in a hypertensive state(during surgery)

Study Sites (1)

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