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

NCT ID: NCT03021109

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Dehydration Acute Gastroenteritis

Keywords

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ultrasound pediatrics gastroenteritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Inferior vena cava diameteres

Measurement of inferior vena cava diameters with ultrasound

Group Type EXPERIMENTAL

Measurement of inferior vena cava diameters with ultrasound

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Derince Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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ASIM ENES ÖZBEK

Emergency medicine specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asım E. Özbek, Specialist

Role: PRINCIPAL_INVESTIGATOR

Kocaeli Derince Training and Research Hospital

Locations

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Kocaeli Derince Training and Research Hospital

Kocaeli, Izmit, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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van den Berg J, Berger MY. Guidelines on acute gastroenteritis in children: a critical appraisal of their quality and applicability in primary care. BMC Fam Pract. 2011 Dec 2;12:134. doi: 10.1186/1471-2296-12-134.

Reference Type BACKGROUND
PMID: 22136388 (View on PubMed)

Liebelt EL. Clinical and laboratory evaluation and management of children with vomiting, diarrhea, and dehydration. Curr Opin Pediatr. 1998 Oct;10(5):461-9. doi: 10.1097/00008480-199810000-00002.

Reference Type BACKGROUND
PMID: 9818241 (View on PubMed)

Steiner MJ, DeWalt DA, Byerley JS. Is this child dehydrated? JAMA. 2004 Jun 9;291(22):2746-54. doi: 10.1001/jama.291.22.2746.

Reference Type BACKGROUND
PMID: 15187057 (View on PubMed)

McConnochie KM, Conners GP, Lu E, Wilson C. How commonly are children hospitalized for dehydration eligible for care in alternative settings? Arch Pediatr Adolesc Med. 1999 Dec;153(12):1233-41. doi: 10.1001/archpedi.153.12.1233.

Reference Type BACKGROUND
PMID: 10591299 (View on PubMed)

Haciomeroglu P, Ozkaya O, Gunal N, Baysal K. Venous collapsibility index changes in children on dialysis. Nephrology (Carlton). 2007 Apr;12(2):135-9. doi: 10.1111/j.1440-1797.2006.00700.x.

Reference Type BACKGROUND
PMID: 17371335 (View on PubMed)

Related Links

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http://www.who.int/mediacentre/factsheets/fs330/en/

Related Info

Other Identifiers

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2016/278

Identifier Type: -

Identifier Source: org_study_id