Closed-loop Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring

Hemodynamic (MAP) Stability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111055
• Other study ID #: P2018-276
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: July 20, 2018

Study information

• Verified date: November 2019
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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%

Related Conditions & MeSH terms

• Hemodynamic (MAP) Stability

Intervention

Device:
• Closed-loop system
the CLV system will correct hypotension by automated adjustment of norepinephrine.

Locations

Country	Name	City	State
Belgium	Erasme	Brussels

Sponsors (3)

Lead Sponsor	Collaborator
Erasme University Hospital	University of California, Irvine, University of California, Los Angeles

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of case time in hypotension	% of case time without hypotension. MAP of at least 5mmHg below the chosen CLV target	during surgery
Secondary	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
Secondary	Amount of vasopressor used	Amount of vasopressor administered to the patient	during surgery
Secondary	Incidence of acute kidney injury	Incidence of acute kidney injury defined with the KDIGO classification	30 days postsurgery