NCT04559178

Brief Summary

The goal of this prospective observational study is to assess the impact of fluid challenge administration on macro and microcirculation in patients situated in the gray zone during a high risk abdominal surgery

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

September 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

September 16, 2020

Last Update Submit

September 19, 2022

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Microvascular flow index

    Comparison of this index before and after the fluid challenge

    day 0

Interventions

Fluid challengeOTHER

fluid challenge administration when patient is in the gray zone

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for a high-risk abdominal surgery and equipped with a minimally uncalibrated pulse contour analysis monitoring device as part of their anesthetic care. All patients will have the hemodynamic monintoring to assess macrocirculation and sublingual microcirculation.

You may qualify if:

  • Patients undergoing a high-risk abdominal surgery
  • Patients equipped with a minimally invasive cardiac output monitoring device in order to optimize fluid administration

You may not qualify if:

  • Atrial fibrillation
  • Ejection fraction \<40%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bicetre hospital

Le Kremlin-Bicêtre, Val De Marne, 94270, France

Location

Study Officials

  • Alexandre JOOSTEN, MD PhD

    ERASME

    STUDY DIRECTOR

  • Alexandra Colesnicenco, MD

    ERASME

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 22, 2020

Study Start

January 25, 2021

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations

FR(1)