Closed-loop Control Mean Arterial Pressure In Intensive Care Patients

Study Overview
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Brief Summary
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The purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard hemodynamic monitor (EV1000 Monitor) from Edwards Lifesciences (IRVINE, USA) in critically ill patients

Detailed Description
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In this protocol, the investigators will report the percentage of case time in hypotension (defined as Mean arterial pressure (MAP) < 72mmHg) during a two hours study protocol in critically ill patients. The target MAP will be set at 80 mmHg, and the definition of hypotension is a MAP < 90% of MAP target ( 80 mmHg - 10% = 72 mmHg) The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point. The investigators will test the system in a short series of 10-12 critically ill patients in the ICU setting during a two hours study protocol. Participants will receive standard patient care Fluids will be given as a baseline crystalloid administration set at 1-2 ml/kg/h

Official Title
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Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Case Series

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: Closed-loop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients in the intensive care unit (awake or under sedation) Requiring norepinephrine to maintain a MAP of 80 mmHg Equiped with an arterial line Exclusion Criteria: Subjects under 18 years of age Subject with Atrial Fibrillation Subjects who are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single prospective single center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed-loop<br>Closed-loop administration of norepinephrine in critically ill patients | Device: Closed-loop<br>* The system will be tested to see if it can avoid hypotension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of case Time in hypotension (MAP <72 mmHg) | The primary outcome will be the percentage of case time in predefined MAP target | During thetwo hours study protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of case time with MAP >88 mmHg with norepinephrine still running | overtreatment | During the two hours study protocol | 
| Amount of vasopressors received | Amount of vasopressors received (norepinephrine) | During the two hours study protocol |