Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000653965
Ethics application status
Approved
Date submitted
2/10/2007
Date registered
27/06/2011
Date last updated
27/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trial of two different fluids for diabetic ketoacidosis
Scientific title
Randomised, controlled trial of Hartmann's solution versus saline in diabetic ketoacidosis in children
Secondary ID [1] 262469 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic ketoacidosis 2416 0
Condition category
Condition code
Metabolic and Endocrine 2523 2523 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hartmann's solution (compound sodium lactate),given intravenously at a rate to correct dehydration over 48 hours, plus usual maintenance fluid requirement. Dehydration is assumed to be 6% if pH is >7.1 and 10% if pH <7.1. Study fluid will be continued until the patient is not vomiting, is drinking, and for at least 12 hours.
Intervention code [1] 2140 0
Treatment: Other
Comparator / control treatment
normal (0.9%) saline, given intravenously at a rate to correct dehydration over 48 hours, plus usual maintenance fluid requirement. Dehydration is assumed to be 6% if pH is >7.1 and 10% if pH <7.1. Study fluid will be continued until the patient is not vomiting, is drinking, and for at least 12 hours.
Control group
Active

Outcomes
Primary outcome [1] 3421 0
time to resolution of acidosis: venous bicarbonate concentration >15 mmol/l
Timepoint [1] 3421 0
Primary outcome is the time from admission to the first bicarbonate measurement reaching 15 mmol/l
Secondary outcome [1] 5681 0
time to reach venous pH of 7.3
Timepoint [1] 5681 0
Secondary outcome is the time from admission to the first venous pH measurement of 7.3
Secondary outcome [2] 5682 0
Time to commence subcutaneous insulin
Timepoint [2] 5682 0
Time to commence subcutaneous insulin from time of randomisation

Eligibility
Key inclusion criteria
Children admitted to paediatric intensive care or high dependency with diabetic ketoacidosis, including pH<7.3 and/or bicarbonate <15 mmol/l who require intravenous fluid
Minimum age
1 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Glasgow coma score <11
Mechanical ventilation
Hyponatraemia: corrected Na <130 mmol/l
Potassium >5.5 mmol/l
Previous enrolment in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible subjects giving consent will be assigned the next available study number from a list. The correspondingly numbered, double, opaque envelope contains a slip of paper stating "fluid A" or "fluid B". These will correspond to either normal saline or Hartmann's solution.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers, stratified by severity (pH<7.1) and previous history of diabetes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2669 0
Self funded/Unfunded
Name [1] 2669 0
Country [1] 2669 0
Australia
Primary sponsor type
Individual
Name
Michael Yung
Address
Women's and Children's Hospital, 72 Kingwilliam Road, North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 2412 0
None
Name [1] 2412 0
Address [1] 2412 0
Country [1] 2412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4588 0
CYWHS Research Ethics Committee
Ethics committee address [1] 4588 0
Women's and Children's Hospital, Kingwilliam Road, North Adelaide SA 5006
Ethics committee country [1] 4588 0
Australia
Date submitted for ethics approval [1] 4588 0
Approval date [1] 4588 0
24/09/2007
Ethics approval number [1] 4588 0
10/06/1971

Summary
Brief summary
We want to know the best type of intravenous (drip) fluid to give children with diabetic ketoacidosis.
There are several kinds of intravenous fluids commonly given to children with diabetic ketoacidosis. The commonest one is normal saline, which is salt dissolved in water. This is the one we use at the Women’s and Children’s hospital. Another fluid sometimes used is called Hartmann’s solution, which contains salt and another substance, lactate, to prevent the build up of acid (acidosis) in the blood that can be caused by too much salt.
One difference between different fluids could be their effect on the recovery from acidosis. All children with diabetic ketoacidosis have acidosis when they are admitted. As they recover from this kind of acidosis, some develop another kind of acidosis, perhaps due to excessive salt. We want to know whether using Hartmann’s solution instead of normal saline will prevent this type of acidsosis, and perhaps speed their recovery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28084 0
Address 28084 0
Country 28084 0
Phone 28084 0
Fax 28084 0
Email 28084 0
Contact person for public queries
Name 11241 0
Michael Yung
Address 11241 0
Paediatric intensive care unit, Women's and Children's Hospital, 72 Kingwilliam road, North Adelaide SA 5006
Country 11241 0
Australia
Phone 11241 0
+61 8 81616479
Fax 11241 0
+61 8 81617457
Email 11241 0
[email protected]
Contact person for scientific queries
Name 2169 0
Michael Yung
Address 2169 0
Paediatric intensive care unit, Women's and Children's Hospital, 72 Kingwilliam road, North Adelaide SA 5006
Country 2169 0
Australia
Phone 2169 0
+61 8 81616479
Fax 2169 0
+61 8 81617457
Email 2169 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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