NCT02203123

Brief Summary

  • There is no definite tool for measurement of dehydration in children
  • Subjective clinical dehydration scale is considered as valuable scoring system, but it cannot be reliable among clinicians sometimes.
  • Some authors found Inferior vena cava/Aorta ratio can be a objective marker for dehydration
  • However, there is no evidence of correlation between clinical dehydration scale and inferior vena cava/aorta ratio
  • We will observe correlation between clinical dehydration scale and inferior vena cava/aorta ratio and change of the ratio according to hydration with intravenous normal saline infusion.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

1.1 years

First QC Date

June 17, 2014

Last Update Submit

July 28, 2014

Conditions

Dehydration

Outcome Measures

Primary Outcomes (1)

  • diameter of inferior vena cava and aorta

    we will measure the diameter of inferior vena cava and aorta using ultrasound during every 10 ml/kg infusion of intravenous normal saline

    up to 2 hours

Study Arms (1)

Ultrasound, inferior vena cava, aorta, normal saline

OTHER
Device: UltrasoundDrug: normal saline

Interventions

UltrasoundDEVICE
Ultrasound, inferior vena cava, aorta, normal saline
normal salineDRUG
Ultrasound, inferior vena cava, aorta, normal saline

Eligibility Criteria

Age3 Months - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children with dehydration who visit emergency department

You may not qualify if:

  • congenital heart disease
  • bronchopulmonary dysplasia
  • renal disease
  • liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Gumi-dong, Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Dehydration

Interventions

UltrasonographySaline Solution

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jin Hee Lee, Professor

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Hee Lee, Professor

CONTACT

+82-31-787-7575gienee@snubh.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 17, 2014

First Posted

July 29, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2015

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

KR(1)