Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000498291
Ethics application status
Approved
Date submitted
17/06/2009
Date registered
23/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can Ultrasound assist assessment of dehydration in diabetic ketoacidosis.
Scientific title
Paediatric Diabetic Ketoacidosis - Prospective measurement of Inferior Vena Cava to Aortic diameter ratio by bedside ultrasound to assess dehydration.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Ketoacidosis 237052 0
Dehydration 237053 0
Condition category
Condition code
Metabolic and Endocrine 237373 237373 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Emergency Department Bedside Ultrasound measurement of the Inferior Vena Cava and Abdominal Aorta. Method involves measuring antero-posterior and transverse diameters using a single transverse ultrasound view in the supine position. Procedure takes approximately 5 to 10 minutes.
Assessment is performed upon admission to the emergency department and upon discharge from hospital and compared to their measured dehydration as defined by admission and discharge weights.
Intervention code [1] 236774 0
Diagnosis / Prognosis
Comparator / control treatment
Degree of dehydration as measured by weight upon admission and discharge
Control group
Active

Outcomes
Primary outcome [1] 238177 0
Relationship between Inferior Vena Cava/Aorta ratio and degree of dehydration. Dehydration will be measured by comparing their admission weight (dehydrated state) to their discharge weight (rehydrated state.)
Timepoint [1] 238177 0
As assessed upon admission and discharge from hospital
Secondary outcome [1] 244504 0
Nil
Timepoint [1] 244504 0
Nil

Eligibility
Key inclusion criteria
Diabetic Ketoacidosis
Presentation to EMergency Department at CHildren's Hospital Westmead
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Life-threatening illness

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237172 0
Hospital
Name [1] 237172 0
Children's Hospital at Westmead
Country [1] 237172 0
Australia
Primary sponsor type
Hospital
Name
Children's Hospital at Westmead
Address
Corner of Hainsworth and Hawkesbury road, Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 4672 0
None
Name [1] 4672 0
Address [1] 4672 0
Country [1] 4672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239266 0
Westmead CHildren's Hospital Research Ethics Committee
Ethics committee address [1] 239266 0
CHildren's Hospital at Westmead, Corner of Hawkesbury road and Hainsworth Road, Westmead, 2145, NSW
Ethics committee country [1] 239266 0
Australia
Date submitted for ethics approval [1] 239266 0
Approval date [1] 239266 0
23/03/2008
Ethics approval number [1] 239266 0
08/CHW/21

Summary
Brief summary
The study is designed to assess the usefulness of ultrasound measurement of inferior vena cava:aorta diameter in assessing dehydration. Children with diabetic ketoacidosis are chosen because they are reliably dehydrated. Dehydration is being quantified by weight measurements at the same time as ultrasound assessment - upon admission and discharge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29764 0
Address 29764 0
Country 29764 0
Phone 29764 0
Fax 29764 0
Email 29764 0
Contact person for public queries
Name 13011 0
Davinder Gill
Address 13011 0
CHildren's Hospital at Westmead
Corner of Hawkesbury Road and Hainsworth Road, Westmead, 2145, NSW
Country 13011 0
Australia
Phone 13011 0
+61 2 98450000
Fax 13011 0
Email 13011 0
davindeg@chw.edu.au
Contact person for scientific queries
Name 3939 0
Davinder Gill
Address 3939 0
CHildren's Hospital at Westmead, COrner of Hawkesbury road and Hainsworth Road, Westmead, 2145, NSW
Country 3939 0
Australia
Phone 3939 0
+61 2 98450000
Fax 3939 0
Email 3939 0
davindeg@chw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.