NCT05111132

Brief Summary

This study will be conducted on pediatric patients up to 14 years of age. The effect of two fluid challenge regimes on cerebral and peripheral NIRS will be assessed, in a randomized double blinded controlled trial. The findings will be correlated with two ultrasound measures, previously validated as markers of fluid responsiveness.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 27, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

October 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

October 27, 2021

Last Update Submit

January 20, 2023

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (3)

  • Effect of fluid challenge on quadricipital NIRS

    We will assess the effect of fluid challenge on muscular quadricipital in correlation with validated parameters for fluid therapy (dynamic parameters measured by ultrasound: IVC distensibility indec, Vmax aorta)

    6 hours

  • Effect of fluid challenge on deltoid NIRS

    We will assess the effect of fluid challenge on muscular deltoid NIRS in correlation with validated parameters for fluid therapy (dynamic parameters measured by ultrasound: IVC distensibility indec, Vmax aorta)

    6 hours

  • Effect of fluid challenge on cerebbral NIRS

    We will assess the effect of fluid challenge on cerebral NIRS in correlation with validated parameters for fluid therapy (dynamic parameters measured by ultrasound: IVC distensibility indec, Vmax aorta)

    6 hours

Study Arms (2)

7.5 ml/kg

EXPERIMENTAL

Group 1, receiving a fluid challenge of 7,5 ml/kg in 5 minutes

Diagnostic Test: Fluid challenge (cristalloïd, NaCl 0,9%)

12.5 ml/kg

EXPERIMENTAL

Group 2, 12.5 ml/kg of fluid challenge in 5 minutes

Diagnostic Test: Fluid challenge (cristalloïd, NaCl 0,9%)

Interventions

Fluid challenge (cristalloïd, NaCl 0,9%)DIAGNOSTIC_TEST

A fluid challenge according to group will be administrated by infusion pump

12.5 ml/kg7.5 ml/kg

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • all operations excepting cardiac surgery
  • BMI \< 30
  • ages 1-14 years

You may not qualify if:

  • any cardiac affection (congenital unoperated heart disease, arrythmias)
  • icterus
  • refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Hospital

Brussels, 1070, Belgium

RECRUITING

Study Officials

  • Pierre Pandin, MD

    Medical doctor

    STUDY DIRECTOR

Central Study Contacts

Pierre Pandin, MD

CONTACT

+3225555812Pierre.Pandin@erasme.ulb.ac.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 27, 2021

First Posted

November 8, 2021

Study Start

October 29, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

January 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)