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Ratio of Inferior Vena Cava and Aorta Diameter in Dehydrated Children

Primary Purpose

Dehydration

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ultrasound

normal saline

About this trial

This is an interventional treatment trial for Dehydration

Eligibility Criteria

3 Months - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All children with dehydration who visit emergency department

Exclusion Criteria:

congenital heart disease
bronchopulmonary dysplasia
renal disease
liver disease

Sites / Locations

Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ultrasound, inferior vena cava, aorta, normal saline

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02203123

First Posted

June 17, 2014

Last Updated

July 28, 2014

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02203123

Brief Title

Ratio of Inferior Vena Cava and Aorta Diameter in Dehydrated Children

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Unknown status

Study Start Date

March 2014 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dehydration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound, inferior vena cava, aorta, normal saline

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Ultrasound

Intervention Type

Drug

Intervention Name(s)

normal saline

Primary Outcome Measure Information:

Title

diameter of inferior vena cava and aorta

Description

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

Time Frame

up to 2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All children with dehydration who visit emergency department Exclusion Criteria: congenital heart disease bronchopulmonary dysplasia renal disease liver disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jin Hee Lee, Professor

Phone

+82-31-787-7575

gienee@snubh.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin Hee Lee, Professor

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Gumi-dong, Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Hee Lee, Professor

Phone

+82-31-787-7575

gienee@snubh.org

12. IPD Sharing Statement

Learn more about this trial

Ratio of Inferior Vena Cava and Aorta Diameter in Dehydrated Children

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