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Completed

NCT Number: NCT03021109

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

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

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Key information

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli Derince Training and Research Hospital

Kocaeli, Izmit, 41900, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of inferior vena cava diameters with ultrasound

Device

The patient is placed in the supine position. Curvilinear probe is used. Subxiphoid view is obtained. The IVC is visualized in the longitudinal plane as it enters the right atrium. The diameter of the IVC for calculation of the caval index is measured 2 cm from where it enters the right atrium

Primary outcomes

  1. The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis

    Time frame: 1 week

Secondary outcomes

  1. The correlation between physical examination findings and the amount of fluid loss in pediatric dehydration

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Derince Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 13, 2017
Registry last updated
Oct 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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