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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03599973
Enrollment
30
Registered
2018-07-26
Start date
2018-08-15
Completion date
2019-07-01
Last updated
2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid and Electrolyte Imbalance, Fluid Therapy

Keywords

Rehydration Solutions

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.

Interventions

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.

Sponsors

Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Aortic VTI changeFrom baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).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).

Secondary

MeasureTime frameDescription
Blood pressure changeFrom baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).Analysis of the variation of Mean Arterial Blood pressure with fluid therapy
Legs-up maneuverFrom baseline analysis (t=5 min after anesthesia induction), to the end of legs-up maneuver (t = +/- 10 min).Analysis of the variation of Mean Arterial Blood pressure with the legs up maneuver
Post-operative nausea and vomitingFrom arrival at PACU (end of surgery) until discharge from PACU (tipically after 1 to 2 hours after the arrival to the PACU)Comparisson of the incidence of post-operative nausea and vomiting in the fluid respondeurs group vs non respondeurs.

Countries

Belgium

Contacts

Primary ContactIonut Tabolcea, MD
ionutztb@yahoo.com0032488720046
Backup ContactWendy Fernandez, MD
fernandez.villarreal.wendy@gmail.com0032487100516

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026