NCT04357301

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 operating room hemodynamic monitoring (EV1000 monitoring device, Edwards Lifesciences, Irvine, USA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

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
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

April 19, 2020

Last Update Submit

March 11, 2021

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Percentage of case Time in hypotension (SAP <117 mmHg)

    The primary outcome will be the percentage of case time in predefined SAP target (SAP of 130 mmHg -10 % = 117 mmHg)

    At postoperative day 1

Secondary Outcomes (3)

  • Amount of vasopressors received

    At postoperative day 1

  • Number of vasopressors infusion rate modifications

    At postoperative day 1

  • Percentage of case time with a MAP < 65 mmHg

    At postoperative day 1

Study Arms (1)

Closed-loop

EXPERIMENTAL

Closed-loop administration of norepinephrine

Device: Closed-loop vasopressor

Interventions

Closed-loop vasopressorDEVICE

The system will adjust the norepineprhine infusion rate based on a target SAP of 130 mmHg in 20 patients

Closed-loop

Eligibility Criteria

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

You may qualify if:

  • Adult patients (age of \>17)
  • Elective high-risk abdominal surgery
  • Patients with an arterial line and in whom a goal directed fluid therapy protocol is applied manually (administration of fluid bolus to maintain a stroke volume variation \< 13%)

You may not qualify if:

  • Atrial Fibrillation
  • Pregnancy
  • Subjects without the capacity to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Alexandre Joosten, MD PhD

    ERASME

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single prospective pilot study (12 patients)
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

October 30, 2020

Study Completion

October 30, 2020

Last Updated

March 15, 2021

Record last verified: 2021-03

Locations

BE(1)