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

October 14, 2017 updated by: ASIM ENES ÖZBEK, Derince Training and Research Hospital

Assessment of Volume Status by Measurement of Caval Index 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Izmit
      • Kocaeli, Izmit, Turkey, 41900
        • Kocaeli Derince Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inferior vena cava diameteres
Measurement of inferior vena cava diameters with ultrasound
Device: Measurement of inferior vena cava diameters with ultrasound
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
The correlation between physical examination findings and the amount of fluid loss in pediatric dehydration
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derince Training and Research Hospital

Investigators

  • Principal Investigator: Asım E. Özbek, Specialist, Kocaeli Derince Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

October 17, 2017

Last Update Submitted That Met QC Criteria

October 14, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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