Dehydration, Hypernatremia, Hypokalemia, Hyponatremia
Conditions
Keywords
Isotonic, Hypotonic, Intravenous fluids
Brief 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.
Interventions
DRUGPlasmalyte Glucos 50 mg/mL
Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.
Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.
Sponsors
Oulu University Hospital
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of children with a clinically significant electrolyte disorder | Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days. | Plasma potassium concentration\<3.5 mmol/L, or hypernatremia \>148 mmol/L, or hyponatremia \<132 mmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of children with hypernatremia | Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days. | Plasma sodium concentration of higher than 148 mmol/L. |
| Proportion of children with hypokalemia | 0-7 days from study entry | Potassium \< 3.5 mmol/L |
| Proportion of children with severe hypokalemia | 0-7 days from study entry | Hypokalemia defined as concentration of potassium \<3.0 mmol/L |
| Fluid retention (g) measured by the weight change | 0-7 days: Body weight is measured daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days. | Weight (g) at discharge - weight (g) at admission |
| Concentration of copeptin in plasma samples | 6-24 hours after study entry | Copeptin plasma concentration |
| Concentration of bicarbonate (HCO3) in plasma samples | 1-3 days after study entry | Plasma concentration of bicarbonate HCO3 |
| Proportion of children with hyponatremia | Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days. | Plasma sodium concentration of lower than 132 mmol/L. |
| Alkalosis measured by base excess (BE) in blood gas analysis | 1-3 days after study entry | Base excess in the blood gas analysis |
| Duration of intravenous fluid therapy | From randomization up to seven days. | Hours from study entry to the stop of fluid therapy |
| Proportion of children who needed change of the study fluid treatment | From randomization up to seven days. | Any change of the fluid used in the treatment |
| Proportion of children admitted to ICU | From randomization up to seven days. | Admission to ICU for any reason |
| Time to discharge from hospital in hours | From randomization up to seven days. | Time from study entry to discharge in hours |
| Number of deaths | 0-30 days from study entry | Any death during the study |
| Acidosis measured by pH in blood gas analysis | 1-3 days after study entry | pH in the blood gas analysis |
Countries
Finland
Outcome results
None listed