AnesthesiaPEDIFLUIDNCT02894996
Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?
A study testing fluid challenge in people with Anesthesia, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 11 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- fluid challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2016to 2 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patient for scheduled surgery
- from 8 to 30 kg of weight
Who cannot join
- denied from the child or their parents
- congenital cardiopathy
- cardiovascular shunt
- respiratory dysfunction
- hepatic dysfunction
- renal dysfunction
- intracranial hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- fluid challenge
- Keywords
- pediatric, anesthesia, fluid responsiveness, hemodynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid challengeDrug
Also called fluid bolus
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.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patient for general anesthesia | Other | Pediatric patients for general anesthesia elected for scheduled surgery Patients weight between 8 and 30 kilograms Receives: Drug: fluid challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 minutes
Secondary outcomes (2)
Correlations between stroke volume variation after expansion of 3mL/Kg and after 15mL/Kg
To compare the correlations between stroke volume variation after volume expansion of 3 mL/kg and after volume expansion of 15 mL/kg
Measured: 12 minutes
Diagnostic capacity of PVI and esophageal doppler
To assess the capacity of the PVI and of common parameters obtained by esophageal Doppler in diagnosing fluid responsiveness
Measured: 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start28 Sep 2016
- Primary completion2 Feb 2018
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Lilot, MD, Principal investigator, Hospices Civils de Lyon Direction de la Recherche Clinique et de l'Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894996
- Sponsor's protocol ID
- 69HCL16_0444
- Other IDs
- 2016-A01192-49
- Acronym
- PEDIFLUID
- Status last verified
- Aug 2025
- First submitted
- 4 Sep 2016
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31858641
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Elective Pediatric Anesthetized Patient?
- ClinicalTrials.gov ID
- NCT02894996
- Acronym / sponsor ID
- PEDIFLUID / 69HCL16_0444
- Conditions
- Anesthesia
- Keywords
- pediatric, anesthesia, fluid responsiveness, hemodynamic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patient for general anesthesia | Other | Drug: fluid challengePediatric patients for general anesthesia elected for scheduled surgery Patients weight between 8 and 30 kilograms |
Who may qualify
- Ages
- 6 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- pediatric patient for scheduled surgery
- from 8 to 30 kg of weight
Key exclusion criteria (7 listed)
- denied from the child or their parents
- congenital cardiopathy
- cardiovascular shunt
- respiratory dysfunction
- hepatic dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluid challengeAlso: fluid bolusfluid 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. | Drug | Pediatric patient for general anesthesia |
Primary outcome
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.
2 secondary outcomes
Correlations between stroke volume variation after expansion of 3mL/Kg and after 15mL/Kg
Time frame: 12 minutes
Diagnostic capacity of PVI and esophageal doppler
Time frame: 12 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 31858641Zorio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Lilot, MD principal investigator
Hospices Civils de Lyon Direction de la Recherche Clinique et de l'Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluid challenge in people with Anesthesia, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke volume variation (time frame: 12 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02894996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.