Computer Assisted Vasopressor Titration in Critically Ill Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Closed-Loop Communication
• Intervention / Treatment: Device: closed-loop system for vasopressor administration

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Anderlecht
    • Brussels, Anderlecht, Belgium, 1070
      • Erasme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Closed-loop; Pilot study: one single group of 10 ICU patients.	Device: closed-loop system for vasopressor administration; The closed-loop system' goal is to keep MAP within 5 mmHg of the predefined target MAP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Amount of vasopressors received	Amount of vasopressors received	48 hours post-admission in the intensive care
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
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

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Alexandre J MD, PhD, Erasme

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Vasoconstrictor Agents
• Other Study ID Numbers: P2018276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No