Computer Assisted Vasopressor Titration in Critically Ill Patients

NCT04106791 | Completed

• 1 other identifier: P2018276
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Closed-Loop Communication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

  48 hours post-admission in the intensive care

• Amount of vasopressors received

  48 hours post-admission in the intensive care

• Number of vasopressor modifications over the treatment time

  48 hours post-admission in the intensive care

• Limitations of the closed-loop system

  48 hours post-admission in the intensive care

Study Arms (1)

Closed-loop

EXPERIMENTAL

Pilot study: one single group of 10 ICU patients.

Device: closed-loop system for vasopressor administration

Interventions

closed-loop system for vasopressor administration DEVICE

The closed-loop system' goal is to keep MAP within 5 mmHg of the predefined target MAP.

Closed-loop

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme

Brussels, Anderlecht, 1070, Belgium

Location

MeSH Terms

Conditions

Teach-Back Communication

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Alexandre J MD, PhD

  ERASME

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: SINGLE GROUP ASSIGNMENT

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: April 26, 2018
• Primary Completion: September 30, 2018
• Study Completion: October 30, 2018
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)