Closed-loop Control Mean Arterial Pressure In Intensive Care Patients

Free University of Brussels (ULB)

Status: Withdrawn

Conditions: Cardiovascular Diseases

Treatments: Device: Closed-loop

Study type: Interventional

Funder types: Other

Identifiers

NCT04357197

P2020-157

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Closed-loop

Experimental group

Description:

Closed-loop administration of norepinephrine in critically ill patients

Treatment:

Device: Closed-loop