A randomised controlled trial of Plasmalyte148 with 5% dextrose compared to 0.45% sodium chloride with 5% dextrose for maintenance intravenous fluid therapy in hospitalised children.

Phase 3

Recruiting

• Conditions: Prevention of iatrogenic hyponatraemia; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12609000924257
• Lead Sponsor: Royal Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 690

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified