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Trial registered on ANZCTR


Trial ID
ACTRN12605000061639
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
1/08/2005
Date last updated
5/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial of maintenance fluids in paediatric intensive care.
Scientific title
Randomised controlled trial of maintenance fluids in paediatric intensive care: effect on plasma sodium concentration.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children admitted to paediatric intensive care (PICU) 133 0
Condition category
Condition code
Blood 152 152 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Main study: randomised to either traditional maintenance fluid rate or 2/3 this rate as either 0.9% saline or 4% dextrose 0.18% saline for 12 to 24 hours (factorial design).
Secondary study: randomised to 2/3 traditional maintenance rate as either 0.9% saline or 4% dextrose 0.18% saline for 12 to 24 hours.
Comparator / control treatment
4% dextrose 0.18% saline
Control group
Active

Outcomes
Primary outcome [1] 188 0
Change in plasma sodium concentration
Timepoint [1] 188 0
At 12 to 24 hours.
Secondary outcome [1] 430 0
Proportion of subjects whose plasma sodium concentration changed by >5 mmol/L.
Timepoint [1] 430 0
After 12-24 hours.
Secondary outcome [2] 431 0
Rate of change of plasma sodium concentration.
Timepoint [2] 431 0
Per hour.
Secondary outcome [3] 432 0
Change in plasma and urinary osmolarity.
Timepoint [3] 432 0
After 12 to 24 hours.
Secondary outcome [4] 433 0
Adverse neurological events.
Timepoint [4] 433 0
Within 12 to 24 hours.
Secondary outcome [5] 434 0
Frequency of hypoglycaemia.
Timepoint [5] 434 0
Within 12 to 24 hours.
Secondary outcome [6] 435 0
Proportion needing fluid resuscitation boluses.
Timepoint [6] 435 0
Within 12 to 24 hours.
Secondary outcome [7] 436 0
Net fluid balance.
Timepoint [7] 436 0
Within 12 to 24 hours.

Eligibility
Key inclusion criteria
Children over 28 days old admitted to PICU who would normally receive IV maintenance fluids for at least 12 hours.
Minimum age
28 Days
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dysnatraemia (sodium <135mmol/L or >145 mmol/L), glucose <3.5 mmol/L, contra-indications to maintenance fluids (full list available from the chief investigator, includes renal failure, diabetic ketoacidosis, gastroenteritis, raised intra-cranial pressure), previous enrolment, blood tests or IV fluids not indicated.

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)
After enrolment, subjects are assigned the next available study number and allocated a correspondingly numbered, sealed box containing blinded study fluids and instructions on the infusion rate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random number sequence (randplan command from Stata version 8) in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 204 0
Self funded/Unfunded
Name [1] 204 0
Address [1] 204 0
Country [1] 204 0
Primary sponsor type
Hospital
Name
Women's and Children's Hospital Adelaide. Not sponsored financially.
Address
Women's and Children's Hospital, North Adelaide SA Australia
Country
Australia
Secondary sponsor category [1] 153 0
None
Name [1] 153 0
none
Address [1] 153 0
Country [1] 153 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 970 0
Women's and Children's Hospital Adelaide
Ethics committee address [1] 970 0
Ethics committee country [1] 970 0
Australia
Date submitted for ethics approval [1] 970 0
Approval date [1] 970 0
Ethics approval number [1] 970 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35891 0
Address 35891 0
Country 35891 0
Phone 35891 0
Fax 35891 0
Email 35891 0
Contact person for public queries
Name 9282 0
Dr Michael Yung
Address 9282 0
Women's and Children's Hospital Adelaide
72 Kingwilliam Rd
North Adelaide SA 5006
Country 9282 0
Australia
Phone 9282 0
+61 8 81616479
Fax 9282 0
+61 8 81617457
Email 9282 0
yungm@wch.sa.gov.au
Contact person for scientific queries
Name 210 0
Dr Michael Yung
Address 210 0
Women's and Children's Hospital Adelaide
72 Kingwilliam Rd
North Adelaide SA 5006
Country 210 0
Australia
Phone 210 0
+61 8 81616479
Fax 210 0
+61 8 81617457
Email 210 0
michael.yung@cywhs.sa.gov.au