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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Drug: fluid challenge

• Registration Number: NCT02894996
• Lead Sponsor: Hospices Civils de Lyon

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.

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 Timeline

• Study First Submitted: 2016-09-04
• Study First Submitted QC: 2016-09-04
• Study First Posted: 2016-09-09
• Study Start: 2016-09-28
• Primary Completion: 2018-02-02
• Study Completion: 2018-02-02
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric patient for general anesthesia	fluid challenge	Pediatric patients for general anesthesia elected for scheduled surgery Patients weight between 8 and 30 kilograms

Primary Outcome Measures

Name	Time	Method
Stroke volume variation	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.

Secondary Outcome Measures

Name	Time	Method
Correlations between stroke volume variation after expansion of 3mL/Kg and after 15mL/Kg	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
Diagnostic capacity of PVI and esophageal doppler	12 minutes	To assess the capacity of the PVI and of common parameters obtained by esophageal Doppler in diagnosing fluid responsiveness

Trial Locations

Locations (1)

Hopital femme mere enfant; 🇫🇷 Bron, Rhone Alpes, France