Intravenous Fluids in Hospitalised Children

University of Oulu660 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

660

Conditions

Hypokalemia Hyponatremia Hypernatremia Dehydration

Interventions

Plasmalyte Glucos 50 mg/mLDRUG

Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.

0.45% saline in 5% dextroseDRUG

Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oulu University Hospital

Oulu, Finland

Outcomes

Primary Outcomes

Proportion of children with a clinically significant electrolyte disorder

Plasma potassium concentration\<3.5 mmol/L, or hypernatremia \>148 mmol/L, or hyponatremia \<132 mmol/L

Time frame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.

Secondary Outcomes

Proportion of children with hyponatremia

Plasma sodium concentration of lower than 132 mmol/L.

Time frame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.

Proportion of children with hypernatremia

Plasma sodium concentration of higher than 148 mmol/L.

Time frame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.

Proportion of children with hypokalemia

Potassium \< 3.5 mmol/L

Time frame: 0-7 days from study entry

Proportion of children with severe hypokalemia

Hypokalemia defined as concentration of potassium \<3.0 mmol/L

Time frame: 0-7 days from study entry

Fluid retention (g) measured by the weight change

Weight (g) at discharge - weight (g) at admission

Time frame: 0-7 days: Body weight is measured daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.

Concentration of copeptin in plasma samples

Data from ClinicalTrials.gov

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