Erasme
Brussels, Anderlecht, 1070, Belgium
NCT Number: NCT04106791
The purpose of this pilot study is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac Edwards Lifesciences, IRVINE, USA) in 10 to 12 critically ill patients in the intensive care unit.
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Brussels, Anderlecht, 1070, Belgium
The investigators have developed an automated closed-loop system for vasopressor administration . They will test it in critically ill patients. The investigators want to demonstrate that the closed-loop system can maintain mean arterial pressure ( MAP) within a very narrow range (within +/- 5 mmHg of the predefined MAP target) for more than 85 % of the treatment time.
The Investigators have shown this to be the case in simulation studies and in-vivo animal studies and in surgical patients but not yet in the Intensive care unit (ICU). Investigators will recruit 10 to 12 ICU patients equipped with a mini-invasive cardiac output monitoring and under continuous norepinephrine infusion.
These patients will typically include: septic patients, neuro ICU patients, ARDS patients, trauma patients or postoperative patients.
The target MAP will be determined by the ICU physician in charge of the patient.
Fluids will be given standard of care. The closed loop (automated) system will use an infusion pump (Q-Core and chemyx pump) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments of vasopressor (norepinephrine)
The goal is to register a period of two hours of closed-loop control of MAP.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The closed-loop system' goal is to keep MAP within 5 mmHg of the predefined target MAP.
Time frame: 48 hours post-admission in the intensive care
The primary outcome will be the percentage of case time in target
Time frame: 48 hours post-admission in the intensive care
Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)
Time frame: 48 hours post-admission in the intensive care
Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running.
Time frame: 48 hours post-admission in the intensive care
Amount of vasopressors received
Time frame: 48 hours post-admission in the intensive care
Number of vasopressor modifications (increase or decrease infusion rate) over the treatment time
Time frame: 48 hours post-admission in the intensive care
Number of errors, malfunction of the system during the treatment time
Erasme University Hospital
Other
Evaluation of Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Pilot Study
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