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

Fluid Therapy Clinical Trial

Official title:

Corrélation Entre la Longueur de jeûne et la réponse au Remplissage Vasculaire évaluée Par Des Mesures répétées de l'ITV.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03599973
• Other study ID #: ErasmeVTI2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: June 2018
• Source: Erasme University Hospital
• Contact: Ionut Tabolcea, MD
• Phone: 0032488720046
• Email: ionutztb[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fluid and Electrolyte Imbalance
• Fluid Therapy

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood pressure change	Analysis of the variation of Mean Arterial Blood pressure with fluid therapy	From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).
Secondary	Legs-up maneuver	Analysis of the variation of Mean Arterial Blood pressure with the legs up maneuver	From baseline analysis (t=5 min after anesthesia induction), to the end of legs-up maneuver (t = +/- 10 min).
Secondary	Post-operative nausea and vomiting	Comparisson of the incidence of post-operative nausea and vomiting in the fluid respondeurs group vs non respondeurs.	From arrival at PACU (end of surgery) until discharge from PACU (tipically after 1 to 2 hours after the arrival to the PACU)