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

June 29, 2018 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 the evaluation of the diagnostic accuracy of a diagnostic test based on an index obtained by transthoracic cardiac echocardiography for diagnosing fluid responsiveness. This index is the stroke volume variation measured by transthoracic cardiac echography.

The study will include anesthetized patients undergoing scheduled surgery. For hemodynamic optimization, these patients will benefit, early after anaesthetic induction, before the surgical procedure has started, from a fluid challenge of 15ml/kg achieved in two stages (3 ml/Kg then 12 ml/kg) separated by an interval of one minute. Three-time hemodynamic will be analyzed.

  • T0: basal
  • T1: one minute after first vascular filling with 3ml/Kg in 2 minutes
  • T2: one minute after second vascular filling with 12 ml/Kg in 8 minutes which is performed one minute after the end of the first filling (a total of 15 ml/kg)

At each time, we will retrieve a collection of hemodynamic data (stroke volume, cardiac output) obtained by transthoracic echocardiography, standard method to assess fluid responsiveness. And at the same times, the PVI and hemodynamic parameters obtained by esophageal Doppler will be noted.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhone Alpes
      • Bron, Rhone Alpes, France, 69500
        • Hopital Femme Mere Enfant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pediatric patient for general anesthesia
Pediatric patients for general anesthesia elected for scheduled surgery Patients weight between 8 and 30 kilograms
Drug: fluid challenge
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.
Other Names:
  • fluid bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke volume variation
Time Frame: 12 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between stroke volume variation after expansion of 3mL/Kg and after 15mL/Kg
Time Frame: 12 minutes
To compare the correlations between stroke volume variation after volume expansion of 3 mL/kg and after volume expansion of 15 mL/kg
12 minutes
Diagnostic capacity of PVI and esophageal doppler
Time Frame: 12 minutes
To assess the capacity of the PVI and of common parameters obtained by esophageal Doppler in diagnosing fluid responsiveness
12 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Marc Lilot, MD, Hospices Civils de Lyon Direction de la Recherche Clinique et de l'Innovation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2016

Primary Completion (Actual)

February 2, 2018

Study Completion (Actual)

February 2, 2018

Study Registration Dates

First Submitted

September 4, 2016

First Submitted That Met QC Criteria

September 4, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL16_0444
  • 2016-A01192-49 (Other Identifier: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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