Correlation Between Duration of Fasting and Response to Fluid Replenishment, Evaluated With Repeated Measures of VTI.

NCT ID: NCT03599973

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2019-07-01

Brief Summary

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The investigators will study the correlation between the lenght of the fasting before surgery and the need to replenish with intra-venous fluids in children, evaluated with 3 measures of the aortic Integral Time Velocity with transthoracic echocardiography.

Detailed Description

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Conditions

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Fluid and Electrolyte Imbalance Fluid Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patient

One-arm study, where all patients are given the same standard fluidotherapy and anesthetic conditions to compare measures of Aortic VTI before and after the IV fluid.

Group Type OTHER

Plasmalyte A Viaflo

Intervention Type OTHER

Fluid therapy to be given according to the principle of 4-2-1 (4 ml of crystalloid fluid for each of the first 10 kg of weight (0-10 kg), 2 ml of crystalloid fluid for each of the second 10 kg of weight (11-20 kg) and 1 ml of crystalloid fluid for each kg of weight over 20.

Interventions

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Plasmalyte A Viaflo

Fluid therapy to be given according to the principle of 4-2-1 (4 ml of crystalloid fluid for each of the first 10 kg of weight (0-10 kg), 2 ml of crystalloid fluid for each of the second 10 kg of weight (11-20 kg) and 1 ml of crystalloid fluid for each kg of weight over 20.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children aged between 3 and 6 years with a normal ponderal evolution.
* Children with good general status (ASA 1)
* Children whose parents have given the informed authorization to do the study.
* Children seen in the consultation of anesthesiology.
* Children programed to have ambulatory surgery (Amygdalectomy, dental care, dental extraction).

Exclusion Criteria

* Children with more than 6 years of age.
* Children whose parents didn't agree with the study.
* Children enrolled in another study on the 3 months before.
* Children with hearth or lung conditions.
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Erasme Hospital

Brussels, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Ionut Tabolcea, MD

Role: CONTACT

0032488720046

Wendy Fernandez, MD

Role: CONTACT

0032487100516

References

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Pees C, Glagau E, Hauser J, Michel-Behnke I. Reference values of aortic flow velocity integral in 1193 healthy infants, children, and adolescents to quickly estimate cardiac stroke volume. Pediatr Cardiol. 2013 Jun;34(5):1194-200. doi: 10.1007/s00246-012-0628-6. Epub 2013 Jan 24.

Reference Type BACKGROUND
PMID: 23344893 (View on PubMed)

Wang J, Xu E, Xiao Y. Isotonic versus hypotonic maintenance IV fluids in hospitalized children: a meta-analysis. Pediatrics. 2014 Jan;133(1):105-13. doi: 10.1542/peds.2013-2041. Epub 2013 Dec 30.

Reference Type BACKGROUND
PMID: 24379232 (View on PubMed)

Miller A, Mandeville J. Predicting and measuring fluid responsiveness with echocardiography. Echo Res Pract. 2016 Jun;3(2):G1-G12. doi: 10.1530/ERP-16-0008. Epub 2016 May 24.

Reference Type BACKGROUND
PMID: 27249550 (View on PubMed)

Mercado P, Maizel J, Beyls C, Titeca-Beauport D, Joris M, Kontar L, Riviere A, Bonef O, Soupison T, Tribouilloy C, de Cagny B, Slama M. Transthoracic echocardiography: an accurate and precise method for estimating cardiac output in the critically ill patient. Crit Care. 2017 Jun 9;21(1):136. doi: 10.1186/s13054-017-1737-7.

Reference Type BACKGROUND
PMID: 28595621 (View on PubMed)

Singh Y. Echocardiographic Evaluation of Hemodynamics in Neonates and Children. Front Pediatr. 2017 Sep 15;5:201. doi: 10.3389/fped.2017.00201. eCollection 2017.

Reference Type BACKGROUND
PMID: 28966921 (View on PubMed)

Lopez L, Colan SD, Frommelt PC, Ensing GJ, Kendall K, Younoszai AK, Lai WW, Geva T. Recommendations for quantification methods during the performance of a pediatric echocardiogram: a report from the Pediatric Measurements Writing Group of the American Society of Echocardiography Pediatric and Congenital Heart Disease Council. J Am Soc Echocardiogr. 2010 May;23(5):465-95; quiz 576-7. doi: 10.1016/j.echo.2010.03.019. No abstract available.

Reference Type BACKGROUND
PMID: 20451803 (View on PubMed)

Gaspar HA, Morhy SS. The Role of Focused Echocardiography in Pediatric Intensive Care: A Critical Appraisal. Biomed Res Int. 2015;2015:596451. doi: 10.1155/2015/596451. Epub 2015 Oct 28.

Reference Type BACKGROUND
PMID: 26605333 (View on PubMed)

Lai WW, Geva T, Shirali GS, Frommelt PC, Humes RA, Brook MM, Pignatelli RH, Rychik J; Task Force of the Pediatric Council of the American Society of Echocardiography; Pediatric Council of the American Society of Echocardiography. Guidelines and standards for performance of a pediatric echocardiogram: a report from the Task Force of the Pediatric Council of the American Society of Echocardiography. J Am Soc Echocardiogr. 2006 Dec;19(12):1413-30. doi: 10.1016/j.echo.2006.09.001. No abstract available.

Reference Type BACKGROUND
PMID: 17138024 (View on PubMed)

Other Identifiers

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ErasmeVTI2018

Identifier Type: -

Identifier Source: org_study_id

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