Closed-loop Control Mean Arterial Pressure In Intensive Care Patients

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04357197
• Other study ID #: P2020-157
• Status: Withdrawn
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: February 2021
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• Closed-loop
The system will be tested to see if it can avoid hypotension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of case Time in hypotension (MAP <72 mmHg)	The primary outcome will be the percentage of case time in predefined MAP target	During thetwo hours study protocol
Secondary	percentage of case time with MAP >88 mmHg with norepinephrine still running	overtreatment	During the two hours study protocol
Secondary	Amount of vasopressors received	Amount of vasopressors received (norepinephrine)	During the two hours study protocol