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

NCT03599973 | Unknown

• 1 other identifier: ErasmeVTI2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fluid and Electrolyte Imbalance; Fluid Therapy

Keywords

Rehydration Solutions

Outcome Measures

Primary Outcomes (1)

• Aortic VTI change

  Transthoracic echocardiography measures of the Time-Speed Interval in the aortic valve before fluid therapy (baseline) and after fluid therapy (20 ml/kg in 15 minutes).

  From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).

Secondary Outcomes (3)

• Blood pressure change

  From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).

• Legs-up maneuver

  From baseline analysis (t=5 min after anesthesia induction), to the end of legs-up maneuver (t = +/- 10 min).

• Post-operative nausea and vomiting

  From arrival at PACU (end of surgery) until discharge from PACU (tipically after 1 to 2 hours after the arrival to the PACU)

Study Arms (1)

Patient

OTHER

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.

Other: Plasmalyte A Viaflo

Interventions

Plasmalyte A Viaflo 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.

Patient

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

Related Publications (8)

• 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.

  PMID: 23344893 BACKGROUND

• 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.

  PMID: 24379232 BACKGROUND

• 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.

  PMID: 27249550 BACKGROUND

• 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.

  PMID: 28595621 BACKGROUND

• 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.

  PMID: 28966921 BACKGROUND

• 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.

  PMID: 20451803 BACKGROUND

• 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.

  PMID: 26605333 BACKGROUND

• 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.

  PMID: 17138024 BACKGROUND

Central Study Contacts

Ionut Tabolcea, MD

CONTACT

0032488720046; ionutztb@yahoo.com

Wendy Fernandez, MD

CONTACT

0032487100516; fernandez.villarreal.wendy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: July 26, 2018
• Study Start: August 15, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 26, 2018

Record last verified: 2018-06

Locations

BE (1)