Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?

NCT02894996 | Completed

• 2 other identifiers: 69HCL16_04442016-A01192-49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To predict fluid responsiveness in anesthetized pediatric patient is not an easy task although anesthesia provider has to deal with this question on their daily practices. Today, very few parameters can help anesthesia provider to predict fluid responsiveness in the pediatric anesthetized patient. Therefore anesthesia provider are let with fluid challenge with high volume of fluid boluses to see if patient were fluid responsive or not. This could lead to fluid overload and it's associated morbidity. We would like to investigate if the cardiac output response to a mini fluid challenge of 3 ml/kg in 2 minutes would be predictive of the response to an usual fluid challenge of 15 ml/kg in 10 minutes in elective pediatric anesthetized patients.

Conditions

Anesthesia

Keywords

pediatric; anesthesia; fluid responsiveness; hemodynamic

Outcome Measures

Primary Outcomes (1)

• Stroke volume variation

  The main objective is to determine whether the new test "the stroke volume variation after fluid challenge of 3mL/Kg" provides information about fluid responsiveness namely increased cardiac output. This new test will be compared to "gold standard" that is, "the stroke volume variation after standard fluid challenge of 15mL/Kg". It is evaluation of the diagnostic accuracy of a diagnostic test based on an index obtained by transthoracic echocardiography for diagnosing fluid responsiveness. This index is the stroke volume variation.

  12 minutes

Secondary Outcomes (2)

• Correlations between stroke volume variation after expansion of 3mL/Kg and after 15mL/Kg

  12 minutes

• Diagnostic capacity of PVI and esophageal doppler

  12 minutes

Study Arms (1)

Pediatric patient for general anesthesia

OTHER

Pediatric patients for general anesthesia elected for scheduled surgery Patients weight between 8 and 30 kilograms

Drug: fluid challenge

Interventions

fluid challenge DRUG

fluid challenge realized after induction of anesthesia at a steady state, to assess fluid responsiveness and correct hypovolemia. The usual fluid bolus of 15ml/kg in 10 minute will be fragmented in 2 fluid boluses (3ml/kg in 2 minutes followed by measurement of hemodynamic parameter after 1 minute of the end of the 1st fluid bolus and followed by 12 ml/kg in 8 minutes then followed by measurement of hemodynamic parameters after one minute after the end of the 2nd fluid fragmented fluid challenge. Total administered: 15 ml/kg in 11 minutes. end of the study at 12 minutes.

Also known as: fluid bolus

Pediatric patient for general anesthesia

Eligibility Criteria

• Age: 6 Months - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• pediatric patient for scheduled surgery
• from 8 to 30 kg of weight

You may not qualify if:

• denied from the child or their parents
• congenital cardiopathy
• cardiovascular shunt
• respiratory dysfunction
• hepatic dysfunction
• renal dysfunction
• intracranial hypertension

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital femme mere enfant

Bron, Auvergne-Rhône-Alpes, 69500, France

Location

Related Publications (1)

• Zorio V, Lebreton T, Desgranges FP, Bochaton T, Desebbe O, Chassard D, Jacquet-Lagreze M, Lilot M. Does a two-minute mini-fluid challenge predict fluid responsiveness in pediatric patients under general anesthesia? Paediatr Anaesth. 2020 Feb;30(2):161-167. doi: 10.1111/pan.13793. Epub 2020 Jan 20.

  PMID: 31858641 BACKGROUND

Study Officials

• Marc Lilot, MD

  Hospices Civils de Lyon Direction de la Recherche Clinique et de l'Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2016
• First Posted: September 9, 2016
• Study Start: September 28, 2016
• Primary Completion: February 2, 2018
• Study Completion: February 2, 2018
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)