Clinical trial NCT04106791: Computer Assisted Vasopressor Titration in Critically Ill Patients
Official title: Evaluation of Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closed-Loop Communication
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SINGLE GROUP ASSIGNMENT
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

- ICU patients under norepinephrine administration and equipped with a advanced hemodynamic monitoring device

Exclusion Criteria:

* Subjects under 18 years of age
* Subjects not requiring cardiac output monitoring or an arterial line
* Subject with Atrial Fibrillation
* Subjects who are pregnant

Primary outcomes:
measure: Percentage of case Time in target (MAP within 5 mmHg of the predetermined MAP target).
timeFrame: 48 hours post-admission in the intensive care
Secondary outcomes:
measure: Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)
timeFrame: 48 hours post-admission in the intensive care
measure: Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running.
timeFrame: 48 hours post-admission in the intensive care
measure: Amount of vasopressors received
timeFrame: 48 hours post-admission in the intensive care
measure: Number of vasopressor modifications over the treatment time
timeFrame: 48 hours post-admission in the intensive care
measure: Limitations of the closed-loop system
timeFrame: 48 hours post-admission in the intensive care
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme
state: Anderlecht
Study officials:
affiliation: ERASME
name: Alexandre J MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: