NCT04357197

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• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Closed-loop	The system will be tested to see if it can avoid hypotension

Timeline

• Start date: 2020-09-25
• Primary completion: 2020-12-01
• Completion: 2021-01-01
• First posted: 2020-04-22
• Last updated: 2021-02-23