Closed-loop Control Mean Arterial Pressure In Intensive Care Patients

Not Applicable

Withdrawn

• Conditions: Cardiovascular Diseases

• Registration Number: NCT04357197
• Lead Sponsor: Erasme University Hospital

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-22
• Study Start: 2020-09-25
• Primary Completion: 2020-12-01
• Study Completion: 2021-01-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-20
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of case Time in hypotension (MAP <72 mmHg)	During thetwo hours study protocol	The primary outcome will be the percentage of case time in predefined MAP target

Secondary Outcome Measures

Name	Time	Method
percentage of case time with MAP >88 mmHg with norepinephrine still running	During the two hours study protocol	overtreatment
Amount of vasopressors received	During the two hours study protocol	Amount of vasopressors received (norepinephrine)