Assessment of Volume Status by Bedside Ultrasound in Children With Acute Gastroenteritis

Not Applicable

Completed

• Conditions: Acute Gastroenteritis; Dehydration
• Interventions: Device: Measurement of inferior vena cava diameters with ultrasound

• Registration Number: NCT03021109
• Lead Sponsor: Derince Training and Research Hospital

Brief Summary

The purpose of the study is assessment of volume status by bedside ultrasound in children with acute gastroenteritis

Detailed Description

The research will be conducted of emergency medicine department in the Derince Training and Research Hospital. Patients referred to acute gastroenteritis will be included to the study. After initial evaluation, the clinician will inform the principal investigator about the patient. The principal investigator will record the patient's demographic data, contact information, vital signs, history, physical examination findings, and weight. Than expirium and inspirium diameters of vena cava inferior will be measured with the bedside ultrasound and caval index will be calculated. An investigator who have had an ultrasound certification by Emergency Medicine Association of Turkey for six years will make the measurements. After 1 week the patient will called up for re-evaluation. Applicants' weights will be measured again with the same weighing machine. The differences between initial and after one week weight measurement will be accepted as the gold standard method for volume loss. The weight loss of the patient, the dehydration findings detected on physical examination and the caval index will be compared.

Data will be collected on predesigned data sheets, by an investigator and subsequently will be entered into a spreadsheet (Excel 2007; Microsoft, Redmond, WA). All recorded data will be checked by an another investigator to identify possible errors. Results will be submitted at least every two months.

Linear regression will be performed with dehydration as the dependent variable and the caval index as the independent variable.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Status Verified: 2017-10
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01
• Last Update Submitted: 2017-10-14
• Last Update Posted: 2017-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• Patients between 6 months and 18 years of age who presented to the Emergency Department with gastroenteritis

Exclusion Criteria

• congenital heart disease
• chronic liver disease
• chronic renal disease
• patients or parents who doesn't want to enroll the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inferior vena cava diameteres	Measurement of inferior vena cava diameters with ultrasound	Measurement of inferior vena cava diameters with ultrasound

Primary Outcome Measures

Name	Time	Method
The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis	1 week

Secondary Outcome Measures

Name	Time	Method
The correlation between physical examination findings and the amount of fluid loss in pediatric dehydration	1 week

Trial Locations

Locations (1)

Kocaeli Derince Training and Research Hospital; 🇹🇷 Kocaeli, Izmit, Turkey