Randomised controlled trial of maintenance fluids in paediatric intensive care.

Randomised controlled trial of maintenance fluids in paediatric intensive care: effect on plasma sodium concentration.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000061639

Enrollment

Registered

2005-08-01

Start date

2005-03-14

Completion date

Unknown

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

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

28 Days to No maximum

Healthy volunteers

Inclusion criteria

Children over 28 days old admitted to PICU who would normally receive IV maintenance fluids for at least 12 hours.

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.

Outcome results