Computer Assisted Vasopressor Titration in Critically Ill Patients

Study Overview
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Brief Summary
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The purpose of this pilot study is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac Edwards Lifesciences, IRVINE, USA) in 10 to 12 critically ill patients in the intensive care unit.

Detailed Description
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The investigators have developed an automated closed-loop system for vasopressor administration . They will test it in critically ill patients. The investigators want to demonstrate that the closed-loop system can maintain mean arterial pressure ( MAP) within a very narrow range (within +/- 5 mmHg of the predefined MAP target) for more than 85 % of the treatment time. The Investigators have shown this to be the case in simulation studies and in-vivo animal studies and in surgical patients but not yet in the Intensive care unit (ICU). Investigators will recruit 10 to 12 ICU patients equipped with a mini-invasive cardiac output monitoring and under continuous norepinephrine infusion. These patients will typically include: septic patients, neuro ICU patients, ARDS patients, trauma patients or postoperative patients. The target MAP will be determined by the ICU physician in charge of the patient. Fluids will be given standard of care. The closed loop (automated) system will use an infusion pump (Q-Core and chemyx pump) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments of vasopressor (norepinephrine) The goal is to register a period of two hours of closed-loop control of MAP.

Official Title
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Evaluation of Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Pilot Study

Conditions
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Closed-Loop Communication

Intervention / Treatment
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* Device: closed-loop system for vasopressor administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - ICU patients under norepinephrine administration and equipped with a advanced hemodynamic monitoring device Exclusion Criteria: Subjects under 18 years of age Subjects not requiring cardiac output monitoring or an arterial line 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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: SINGLE GROUP ASSIGNMENT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed-loop<br>Pilot study: one single group of 10 ICU patients. | Device: closed-loop system for vasopressor administration<br>* The closed-loop system' goal is to keep MAP within 5 mmHg of the predefined target MAP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of case Time in target (MAP within 5 mmHg of the predetermined MAP target). | The primary outcome will be the percentage of case time in target | 48 hours post-admission in the intensive care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target) | Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target) | 48 hours post-admission in the intensive care | 
| Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running. | Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running. | 48 hours post-admission in the intensive care | 
| Amount of vasopressors received | Amount of vasopressors received | 48 hours post-admission in the intensive care | 
| Number of vasopressor modifications over the treatment time | Number of vasopressor modifications (increase or decrease infusion rate) over the treatment time | 48 hours post-admission in the intensive care | 
| Limitations of the closed-loop system | Number of errors, malfunction of the system during the treatment time | 48 hours post-admission in the intensive care |