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Clinical Trials/ACTRN12609000924257
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?

Royal Children's Hospital0 sites690 target enrollmentOctober 27, 2009

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.

Registry
who.int
Start Date
October 27, 2009
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

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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