Closed-loop Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring
NCT ID: NCT04111055
Last Updated: 2019-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2018-06-15
2018-07-20
Brief Summary
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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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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Closed-loop system
the CLV system will correct hypotension by automated adjustment of norepinephrine.
Interventions
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Closed-loop system
the CLV system will correct hypotension by automated adjustment of norepinephrine.
Eligibility Criteria
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Inclusion Criteria
2. Patients equipped with a clearsight advanced hemodynamic monitoring system
Exclusion Criteria
2. No consent obtained from the patient.
3. Ejection fraction \< 30%
18 Years
99 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
University of California, Irvine
OTHER
Erasme University Hospital
OTHER
Responsible Party
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Alexandre Joosten, MD PhD
Principal Investigator
Principal Investigators
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Alexandre J Joosten, MD PhD
Role: PRINCIPAL_INVESTIGATOR
ERASME
Locations
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Erasme
Brussels, , Belgium
Countries
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Other Identifiers
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P2018-276
Identifier Type: -
Identifier Source: org_study_id
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