Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Case Series
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Erasme University Hospital
- Primary Endpoint
- Percentage of case Time in hypotension (MAP <72 mmHg)
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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
Investigators
Alexandre Joosten, MD PhD
Principal Investigator
Erasme University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Percentage of case Time in hypotension (MAP <72 mmHg)
Time Frame: During thetwo hours study protocol
The primary outcome will be the percentage of case time in predefined MAP target
Secondary Outcomes
- percentage of case time with MAP >88 mmHg with norepinephrine still running(During the two hours study protocol)
- Amount of vasopressors received(During the two hours study protocol)