NCT02926989

Intravenous Fluids in Hospitalised Children

Fluid Therapy in Acutely Ill Children - a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 660 (actual)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Accepted

Summary

The main objective of the trial is to evaluate the risk of hypokalemia following administration of a isotonic solution compared to a hypotonic solution in acutely ill hospitalised children, who need intravenous fluid therapy.

Detailed description

The main objective of the trial is to evaluate the risk of hypokalemia (low plasma potassium concentration) following administration of a Plasmalyte Glucos 50 mg/mL solution compared to a 0.45% saline in 5% dextrose solution in acutely ill hospitalised children, who need intravenous fluid therapy. The secondary objective of the trial is to evaluate the risk of hyponatremia (low plasma sodium concentration) and the risk of hypernatremia (high plasma sodium concentration) following administration of isotonic solution compared to hypotonic solution.

Conditions

• Hypokalemia
• Hyponatremia
• Hypernatremia
• Dehydration

Interventions

Type	Name	Description
DRUG	Plasmalyte Glucos 50 mg/mL	Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.
DRUG	0.45% saline in 5% dextrose	Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.

Timeline

• Start date: 2016-10-03
• Primary completion: 2019-03-31
• Completion: 2019-04-15
• First posted: 2016-10-06
• Last updated: 2019-08-22

Locations

1 site across 1 country: Finland