Intravenous Fluids in Hospitalised Children

University of Oulu

Status and phase: Completed; Phase 4

Conditions: Hypernatremia; Hypokalemia; Dehydration; Hyponatremia

Treatments: Drug: 0.45% saline in 5% dextrose; Drug: Plasmalyte Glucos 50 mg/mL

Study type: Interventional

Funder types: Other

Identifiers

NCT02926989

EETTMK 48/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 660 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Acutely ill hospitalised children
• Need for intravenous fluid therapy

Exclusion criteria

• An initial plasma sodium concentration of lower than 130 mmol/L
• An initial plasma sodium concentration of higher than 150 mmol/L
• An initial plasma potassium concentration of lower than 3.0 mmol/L
• Need for 10% glucose solution
• Diabetes
• Diabetes insipidus
• Diabetic ketoacidosis
• Renal disease that needs dialysis
• Protocol-determined chemotherapy hydration
• Severe liver disease
• Inborn errors of metabolism that need protocol-determined fluid therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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660 participants in 2 patient groups

Isotonic solution

Experimental group

Description:

Plasmalyte Glucos 50 mg/mL; total daily fluid requirements are estimated using the Holiday-Segar method plus possible dehydration (according to child's weight loss during acute illness); intravenous fluids are administered using delivery pumps programmed for an hourly infusion rate (mL/hour); intravenous fluids are administered as long as needed during hospitalization, but no longer than seven days after admission.

Treatment:

Drug: Plasmalyte Glucos 50 mg/mL

Hypotonic solution

Active Comparator group

Description:

0.45% saline in 5% dextrose; total daily fluid requirements are estimated using the Holiday-Segar method plus possible dehydration (according to child's weight loss during acute illness); intravenous fluids are administered using delivery pumps programmed for an hourly infusion rate (mL/hour); intravenous fluids are administered as long as needed during hospitalization, but no longer than seven days after admission.

Treatment:

Drug: 0.45% saline in 5% dextrose