NCT04232007

Brief Summary

Intraoperative hypotension and blood pressure variability are associated with postoperative complications in surgical patients. The investigators have developed a closed-loop vasopressor (CLV) controller that titrates norepinephrine to correct hypotension. After having tested the system in a small cohort series of patients undergoing major surgeries, the investigators aimed to test the feasibility of the CLV controller in three high risk patients undergoing cardiac surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

May 16, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

January 14, 2020

Last Update Submit

January 15, 2020

Conditions

Hemodynamic MAP Stability

Outcome Measures

Primary Outcomes (1)

  • percentage of time spent during surgery in hypotension

    percentage of time spent during surgery in hypotension defined as a MAP below 65 mmHg.

    during surgery

Secondary Outcomes (3)

  • time in target during surgery

    during surgery

  • Percentage of active treatment time spent in a hypertensive state

    during surgery

  • Amount of vasopressor used

    during surgery

Study Arms (1)

Closed-loop

EXPERIMENTAL

Closed-loop system to titrate vasopressor during surgery

Device: closed-loop system for vasopressor administration

Interventions

closed-loop system for vasopressor administrationDEVICE

closed-loop system for vasopressor administration

Closed-loop

Eligibility Criteria

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

You may qualify if:

  • Adult high risk patients undergoing cardiac surgery (robotic, off-pump and on pump cardiac surgery)

You may not qualify if:

  • Atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme

Brussels, Anderlecht, 1070, Belgium

Location

Study Officials

  • Alexandre Joosten

    ERASME

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Closed-loop system to titrate vasopressor
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

May 16, 2018

Primary Completion

August 14, 2018

Study Completion

August 30, 2018

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)