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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.

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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000116426
Enrollment
84
Registered
2007-02-08
Start date
2006-11-01
Completion date
2008-11-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

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).

Sponsors

Dr Mark Coulthard
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026