Ratio of Inferior Vena Cava and Aorta Diameter in Dehydra... | NCT02203123

Studies
Ratio of Inferior Vena Cava and Aorta Diameter in Dehydrated Children

NCT02203123

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jul 29, 2014Estimated

Enrollment

226Estimated

Phase

Not Applicable

Conditions

Dehydration

Interventions

Ultrasound
normal saline

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Apr 2015Estimated

Completion Date

Not provided

First Submitted Date

Jun 17, 2014

First Submission Date that Met QC Criteria

Jul 28, 2014

First Posted Date

Jul 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2014

Last Update Posted Date

Jul 29, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jin Hee Lee, Assistant professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

226Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound, inferior vena cava, aorta, normal saline	Other		Device: Ultrasound Drug: normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Device		Ultrasound, inferior vena cava, aorta, normal saline
normal saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All children with dehydration who visit emergency department

Exclusion Criteria:

congenital heart disease
bronchopulmonary dysplasia
renal disease
liver disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin Hee Lee, Professor	Contact	+82-31-787-7575		gienee@snubh.org

Overall Officials

Name	Affiliation	Role
Jin Hee Lee, Professor	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Gumi-dong, Seongnam-si	Gyeonggi-do	463-707	South Korea

Type	Date	Date Unknown
Release	Jan 6, 2018
Reset	Sep 14, 2018

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 6, 2018			Sep 14, 2018

Condition Browse Module

MeSH Terms

ID	Term
D003681	Dehydration

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography
D000077330	Saline Solution

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D000077324	Crystalloid Solutions

Browse Leaves

Not provided

Browse Branches

Not provided