Computer Assisted Vasopressor Titration in Critically Ill Patients

Closed-Loop Communication Clinical Trial

Official title:

Evaluation of Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106791
• Other study ID #: P2018276
• Status: Completed
• Phase: N/A
• Start date: April 26, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: November 2019
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Closed-Loop Communication
• Critical Illness

Intervention

Device:
• closed-loop system for vasopressor administration
The closed-loop system' goal is to keep MAP within 5 mmHg of the predefined target MAP.

Locations

Country	Name	City	State
Belgium	Erasme	Brussels	Anderlecht

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of case Time in target (MAP within 5 mmHg of the predetermined MAP target).	The primary outcome will be the percentage of case time in target	48 hours post-admission in the intensive care
Secondary	Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)	Percentage of case Time in hypotension (MAP <5 mmHg of the chosen target)	48 hours post-admission in the intensive care
Secondary	Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running.	Percentage of case time with MAP >5 mmHg of the chosen target with vasopressor still running.	48 hours post-admission in the intensive care
Secondary	Amount of vasopressors received	Amount of vasopressors received	48 hours post-admission in the intensive care
Secondary	Number of vasopressor modifications over the treatment time	Number of vasopressor modifications (increase or decrease infusion rate) over the treatment time	48 hours post-admission in the intensive care
Secondary	Limitations of the closed-loop system	Number of errors, malfunction of the system during the treatment time	48 hours post-admission in the intensive care