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

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ClinicalTrials.gov Identifier: NCT02894996
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: fluid challenge Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Elective Pediatric Anesthetized Patient?
Actual Study Start Date : September 28, 2016
Actual Primary Completion Date : February 2, 2018
Actual Study Completion Date : February 2, 2018

Arm Intervention/treatment
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 Name: fluid bolus




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   6 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894996


Locations
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France
Hopital femme mere enfant
Bron, Rhone Alpes, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Marc Lilot, MD Hospices Civils de Lyon Direction de la Recherche Clinique et de l'Innovation
Publications:

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02894996    
Other Study ID Numbers: 69HCL16_0444
2016-A01192-49 ( Other Identifier: ID-RCB )
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Keywords provided by Hospices Civils de Lyon:
pediatric
anesthesia
fluid responsiveness
hemodynamic