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OpenTrials
Completed

NCT Number: NCT04111055

Closed-loop Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme

Brussels, 1070, Belgium

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Closed-loop system

Device

the CLV system will correct hypotension by automated adjustment of norepinephrine.

Primary outcomes

  1. 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

  1. Percentage of active treatment time spent in a hypertensive state

    Time frame: during surgery

    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

  2. Amount of vasopressor used

    Time frame: during surgery

    Amount of vasopressor administered to the patient

  3. Incidence of acute kidney injury

    Time frame: 30 days postsurgery

    Incidence of acute kidney injury defined with the KDIGO classification

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Collaborators

  • University of California, Irvine
  • University of California, Los Angeles

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2019
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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