NCT03021109

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

January 12, 2017

Last Update Submit

October 14, 2017

Conditions

DehydrationAcute Gastroenteritis

Keywords

ultrasoundpediatricsgastroenteritis

Outcome Measures

Primary Outcomes (1)

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

    1 week

Secondary Outcomes (1)

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

    1 week

Study Arms (1)

Inferior vena cava diameteres

EXPERIMENTAL

Measurement of inferior vena cava diameters with ultrasound

Device: Measurement of inferior vena cava diameters with ultrasound

Interventions

Measurement of inferior vena cava diameters with ultrasoundDEVICE

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

Inferior vena cava diameteres

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli Derince Training and Research Hospital

Kocaeli, Izmit, 41900, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 22136388BACKGROUND

  • 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.

    PMID: 9818241BACKGROUND

  • 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.

    PMID: 15187057BACKGROUND

  • 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.

    PMID: 10591299BACKGROUND

  • 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.

    PMID: 17371335BACKGROUND

Related Links

MeSH Terms

Conditions

DehydrationGastroenteritis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Asım E. Özbek, Specialist

    Kocaeli Derince Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency medicine specialist

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 13, 2017

Study Start

December 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 17, 2017

Record last verified: 2017-10

Locations

TU(1)