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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02203123
Other study ID # ultrasound_01
Secondary ID
Status Recruiting
Phase N/A
First received June 17, 2014
Last updated July 28, 2014
Start date March 2014

Study information

Verified date July 2014
Source Seoul National University Hospital
Contact Jin Hee Lee, Professor
Phone +82-31-787-7575
Email gienee@snubh.org
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 226
Est. completion date
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Months to 15 Years
Eligibility Inclusion Criteria:

- All children with dehydration who visit emergency department

Exclusion Criteria:

- congenital heart disease

- bronchopulmonary dysplasia

- renal disease

- liver disease

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Ultrasound

Drug:
normal saline


Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Gumi-dong, Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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