DehydrationNCT02203123
Ratio of Inferior Vena Cava and Aorta Diameter in Dehydrated Children
A study testing Ultrasound and normal saline in people with Dehydration, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 3 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Ultrasound and normal saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children with dehydration who visit emergency department
Who cannot join
- congenital heart disease
- bronchopulmonary dysplasia
- renal disease
- liver disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Gumi-dong, Seongnam-si, Gyeonggi-do, 463-707
Jin Hee Lee, Professor, +82-31-787-7575, gienee@snubh.org
About this study
- 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.
- Conditions
- Dehydration
- Being tested
- Ultrasound, normal saline
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound, inferior vena cava, aorta, normal saline | Other | Not described Receives: Device: Ultrasound; Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Hee Lee, Seoul National University Hospital
- Investigators
- Jin Hee Lee, Professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203123
- Sponsor's protocol ID
- ultrasound_01
- Status last verified
- Jul 2014
- First submitted
- 17 Jun 2014
- Last updated
- 29 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ratio of Inferior Vena Cava and Aorta Diameter in Dehydrated Children
- ClinicalTrials.gov ID
- NCT02203123
- Acronym / sponsor ID
- ultrasound_01
- Conditions
- Dehydration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (estimated)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound, inferior vena cava, aorta, normal saline | Other | Device: Ultrasound, Drug: normal saline |
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children with dehydration who visit emergency department
Key exclusion criteria (4 listed)
- congenital heart disease
- bronchopulmonary dysplasia
- renal disease
- liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound | Device | Ultrasound, inferior vena cava, aorta, normal saline |
| normal saline | Drug | Ultrasound, inferior vena cava, aorta, normal saline |
Primary outcome
diameter of inferior vena cava and aorta
Time frame: up to 2 hours
we will measure the diameter of inferior vena cava and aorta using ultrasound during every 10 ml/kg infusion of intravenous normal saline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Hee Lee, Professor principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and normal saline in people with Dehydration, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Hee Lee, Professor (+82-31-787-7575, gienee@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diameter of inferior vena cava and aorta (time frame: up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.