ACTRN12609000924257
Recruiting
Phase 3
In hospitalised children requiring maintenance intravenous therapy, does Plasmalyte148 with 5% dextrose compared to 0.45% sodium chloride with 5% dextrose result in less hyponatraemia?
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Royal Children's Hospital
- Enrollment
- 690
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be eligible for this study, each subject must be aged between 3 months and 18 years old, be a patient at the Royal Children's Hospital in Melbourne and be assessed by an independent clinician as requiring intravenous fluid therapy at a rate of at least 50% and up to 150% recommended maintenance.
Exclusion Criteria
- •An initial plasma sodium level of \<130 or \>150\. A known abnormality of antidiuretic hormone secretion. Diabetic ketoacidosis. Renal disease requiring dialysis. A known disorder causing excessive renal sodium excretion. Pre or postoperative neurosurgical or craniofacial patients, requiring opening of the cranial cavity. Oncology patients requiring protocol\-determined chemotherapy hydration. Children with inborn errors of metabolism requiring protocol determined fluid therapy. Proven meningitis. Severe liver disease. Conditions where intravenous fluids are anticipated to be given for less than six hours.
Outcomes
Primary Outcomes
Not specified
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