NCT04357197

Brief Summary

The purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard hemodynamic monitor (EV1000 Monitor) from Edwards Lifesciences (IRVINE, USA) in critically ill patients

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable cardiovascular-diseases

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 25, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

April 19, 2020

Last Update Submit

February 20, 2021

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Percentage of case Time in hypotension (MAP <72 mmHg)

    The primary outcome will be the percentage of case time in predefined MAP target

    During thetwo hours study protocol

Secondary Outcomes (2)

  • percentage of case time with MAP >88 mmHg with norepinephrine still running

    During the two hours study protocol

  • Amount of vasopressors received

    During the two hours study protocol

Study Arms (1)

Closed-loop

EXPERIMENTAL

Closed-loop administration of norepinephrine in critically ill patients

Device: Closed-loop

Interventions

Closed-loopDEVICE

The system will be tested to see if it can avoid hypotension

Closed-loop

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients in the intensive care unit (awake or under sedation)
  • Requiring norepinephrine to maintain a MAP of 80 mmHg
  • Equiped with an arterial line

You may not qualify if:

  • Subjects under 18 years of age
  • Subject with Atrial Fibrillation
  • Subjects who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Alexandre Joosten, MD PhD

    ERASME

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single prospective single center study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2020

First Posted

April 22, 2020

Study Start

September 25, 2020

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share