The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000116426
Ethics application status
Approved
Date submitted
30/10/2006
Date registered
8/02/2007
Date last updated
11/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Administration of 5% Dextrose/Hartmann's solution compared with 5% Dextrose/Half Normal (0.45%) Saline following spinal instrumentation surgery or craniotomy in children results in less post-operative hyponatraemia.
Scientific title
In children undergoing spinal instrumentation or craniotomy does post-operative fluid therapy with Hartmann's and 5% Dextrose at maintenance rate(experimental group) compared with 0.45% sodium chloride with 5% dextrose at two-thirds maintenance rate (control) result in less post-operative hyponatraemia.
Secondary ID [1] 287888 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative hyponatraemia 1608 0
Condition category
Condition code
Blood 1712 1712 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly allocated to Hartmann's and 5% Dextrose solution (experimental group). The rate of administration of fluids in the experimental group will be calculated at 100% of full paediatric fluid maintainence requirements. The intravenous fluids will be continued until eneteral feeding is recommenced (approximately 16 - 24hrs).
Intervention code [1] 1423 0
Treatment: Other
Comparator / control treatment
Patients will be randomly allocated to 0.45% Sodium Chloride and 5% Dextrose solution(control group/standard practice). The rate of administration of fluids in the control group will be calculated at 70% of full paediatric fluid maintainence requirements. The intravenous fluids will be continued until eneteral feeding is recommenced (approximately 16 - 24hrs).
Control group
Active

Outcomes
Primary outcome [1] 2383 0
Hyponatraemia is defined as a plasma sodium concentration of less than 135mmol/L and will be measured by arterial blood gas analysis via Radiometer Copenhagen, ABL 725
Timepoint [1] 2383 0
Sodium levels will be measured within 1 hour and 12-16 hours post-operatively.
Secondary outcome [1] 4138 0
Change in serum Antidiuretic Hormone (ADH) levels.
Timepoint [1] 4138 0
Serum ADH levels will be measured at induction of surgery and 16 hrs post-operative.
Secondary outcome [2] 4139 0
Amount of fluid bolus requirements in mls/kg up to 16 hrs post-operative.
Timepoint [2] 4139 0
12-16h post surgery

Eligibility
Key inclusion criteria
* Patients who are admitted to the Paediatric Intensive Care Unit (PICU) (elective or emergency) following spinal fusion or craniotomy surgery. * Spinal fusion surgery includes posterior spinal instrumentation and fusion.* Craniotomy surgery includes excision of tumours and surgical correction of craniostenoses.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Parents/Guardians who are unable to read and write English.* Patients undergoing lengthening only of spinal growth rods, revision/insertion of ventriculoperitoneal (VP) shunts.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation. Stratified by surgical procedure (spinal v craniotomy)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects (patients) and parents are blind.
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 1862 0
Charities/Societies/Foundations
Name [1] 1862 0
Henry Blackwood Trust Fund
Address [1] 1862 0
Royal Children's Hospital Foundation
Herston
Brisbane QLD 4006
Country [1] 1862 0
Australia
Funding source category [2] 1863 0
Charities/Societies/Foundations
Name [2] 1863 0
Royal Children's Hospital Foundation
Address [2] 1863 0
Royal Children's Hospital Foundation
Herston
Brisbane QLD 4006
Country [2] 1863 0
Australia
Primary sponsor type
Individual
Name
Dr Mark Coulthard
Address
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
Country
Australia
Secondary sponsor category [1] 1672 0
Individual
Name [1] 1672 0
Debbie Long
Address [1] 1672 0
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane
Country [1] 1672 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3472 0
Royal Children's Hospital
Ethics committee address [1] 3472 0
Brisbane
Ethics committee country [1] 3472 0
Australia
Date submitted for ethics approval [1] 3472 0
16/12/2005
Approval date [1] 3472 0
01/03/2006
Ethics approval number [1] 3472 0
1/03/2006

Summary
Brief summary
Literature and clinical experience have shown that children undergoing major spinal surgery or craniotomy are at particular risk of low sodium levels. The optimal management of fluid and electrolytes in this group of children has received much attention in the literature, but to date there is still no consensus on this matter. Although many studies have described post-operative hyponatraemia, there has not been to our knowledge a prospectively conducted randomised controlled trial of the post-operative use of hypotonic dextrose/saline (standard paediatric intravenous fluid therapy) versus isotonic saline therapy following major corrective spinal surgery or craniotomy to prevent hyponatraemia in a paediatric population. We will be conducting a randomised controlled trial of Hartmann's and 5% Dextrose compared with 0.45% Sodium Chloride and 5% Dextrose. We hypothesise that Hartman's and 5% Glucouse will minimise the postoperative fall in serum sodium following spinal surgery and craniotomy.
Trial website
Trial related presentations / publications
Published in Archives of Disease in Childhood (2011) 97:491-497
Public notes

Contacts
Principal investigator
Name 27357 0
Dr Mark G Coulthard
Address 27357 0
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country 27357 0
Australia
Phone 27357 0
0418155370
Fax 27357 0
Email 27357 0
Mark.Coulthard@health.qld.gov.au
Contact person for public queries
Name 10612 0
Dr Dr Mark Coulthard
Address 10612 0
Paediatric Intensive Care Unit
Royal Children's Hospital
Herston Road
Herston QLD 4029
Country 10612 0
Australia
Phone 10612 0
+61 7 36365403
Fax 10612 0
+61 7 36361990
Email 10612 0
Mark.Coulthard@health.qld.gov.au
Contact person for scientific queries
Name 1540 0
Dr Debbie Long
Address 1540 0
Paediatric Intensive Care Unit
Royal Children's Hospital
Herston Road
Herston QLD 4029
Country 1540 0
Australia
Phone 1540 0
+61 7 36367957
Fax 1540 0
+61 7 36361990
Email 1540 0
DebbieA_Long@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary