NCT04187274

Brief Summary

The goal of this observational substudy is to evaluate the feasibility, performance and behavior of the IKORUS (Advanced Perfusion Diagnostics, Villeurbanne, France), a new tissue perfusion device using urethral photoplethysmography in patients undergoing major abdominal surgery and in whom an advanced hemodynamic monitoring is placed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

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

September 4, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

December 1, 2019

Last Update Submit

September 18, 2020

Conditions

Technology

Outcome Measures

Primary Outcomes (1)

  • Analysis of uPi evolution during surgery and comparison with Stroke volume

    Percentage of case time with positive correlation between both variables (positive or negative) during a fluid challenge and during the whole case

    during surgery

Secondary Outcomes (1)

  • Occurrence of decreased perfusion during surgery

    during surgery

Interventions

IKORUS technologyDEVICE

Ikorus technology is a new micro perfusion device measuring via urethral photoplethysmography, the urethral perfusion index (uPI) in patients equipped with an urinary catheter.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing major abdominal surgery

You may qualify if:

  • All adult patients undergoing major abdominal surgeries and equipped with an advanced hemodynamic monitoring for goal directed therapy

You may not qualify if:

  • Atrial fibrillation
  • Ejection fraction \< 30%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme Hospital

Brussels, Brussel-hoofdstad, 1070, Belgium

Location

Study Officials

  • JOOSTEN ALEXANDRE, MD PhD

    ERASME

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2019

First Posted

December 5, 2019

Study Start

September 4, 2019

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)