Randomised controlled trial of maintenance fluids in paediatric intensive care.
Phase 3
Active, not recruiting
- Conditions
- Children admitted to paediatric intensive care (PICU)Blood - Haematological diseases
- Registration Number
- ACTRN12605000061639
- Lead Sponsor
- Women's and Children's Hospital Adelaide. Not sponsored financially.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in plasma sodium concentration[At 12 to 24 hours.]
- Secondary Outcome Measures
Name Time Method Proportion of subjects whose plasma sodium concentration changed by >5 mmol/L.[After 12-24 hours.];Rate of change of plasma sodium concentration.[Per hour.];Change in plasma and urinary osmolarity.[After 12 to 24 hours.];Adverse neurological events.[Within 12 to 24 hours.];Frequency of hypoglycaemia.[Within 12 to 24 hours.];Proportion needing fluid resuscitation boluses.[Within 12 to 24 hours.];Net fluid balance.[Within 12 to 24 hours.]