Can Peripheral NIRS Predict the Response to a Fluid Challenge in Pediatric Patients: An Interventional Study

Sponsor

Erasme University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05111132

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Diagnostic Test: Fluid challenge (cristalloïd, NaCl 0,9%)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Can Peripheral NIRS Predict the Response to a Fluid Challenge in Pediatric Patients: An Interventional Study

Anticipated Study Start Date :

Oct 29, 2021

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 7.5 ml/kg Group 1, receiving a fluid challenge of 7,5 ml/kg in 5 minutes	Diagnostic Test: Fluid challenge (cristalloïd, NaCl 0,9%) A fluid challenge according to group will be administrated by infusion pump
Experimental: 12.5 ml/kg Group 2, 12.5 ml/kg of fluid challenge in 5 minutes	Diagnostic Test: Fluid challenge (cristalloïd, NaCl 0,9%) A fluid challenge according to group will be administrated by infusion pump

Arm

Intervention/Treatment

Experimental: 7.5 ml/kg

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

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

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

Experimental: 12.5 ml/kg

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

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

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

Outcome Measures

Primary Outcome Measures

Effect of fluid challenge on NIRS (peripheral/cerebral) [peri-operative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasmus Hospital	Brussels		Belgium	1070

Sponsors and Collaborators

Erasme University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lulia Scolobiuc, Resident, Erasme University Hospital

ClinicalTrials.gov Identifier:

NCT05111132

Other Study ID Numbers:

P2021/055/CCB B4062021000019

First Posted:

Nov 8, 2021

Last Update Posted:

Nov 8, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Nov 8, 2021