Closed-loop Control Mean Arterial Pressure In Intensive Care Patients

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-25

Study Completion Date

2021-01-01

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

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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

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single prospective single center study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Closed-loop

Closed-loop administration of norepinephrine in critically ill patients

Group Type EXPERIMENTAL

Closed-loop

Intervention Type DEVICE

The system will be tested to see if it can avoid hypotension

Interventions

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Closed-loop

The system will be tested to see if it can avoid hypotension

Intervention Type DEVICE

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