Closed-loop Control Mean Arterial Pressure In Intensive Care Patients

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04357197

Enrollment

Registered

2020-04-22

Start date

2020-09-25

Completion date

2021-01-01

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

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

Interventions

DEVICEClosed-loop

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single prospective single center study

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026