Acutely ill hospitalised children who need intravenous fluid therapy.
Conditions
Interventions
Trade Name: Plasmalyte Glucos 50 mg/mL
Pharmaceutical Form: Infusion
Sponsors
Minna Honkila / OYS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acutely ill hospitalised children aged between 6 months and 12 years that need intravenous fluid therapy. Are the trial subjects under 18? yes Number of subjects for this age range: 610 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: An initial plasma sodium concentration of lower than 130 mmol/L or 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 or 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 |
|---|---|
| Main Objective: 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 glucose 5% solution containing potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.;Secondary Objective: The secondary objective of the trial is to evaluate the risk of hyponatremia (low plasma sodium concentration) following administration of a Plasmalyte Glucos 50 mg/mL solution compared to a glucose 5% solution containing potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.;Primary end point(s): Incidence of hypokalemia (plasma potassium concentration of lower than 3.5 mmol/L).;Timepoint(s) of evaluation of this end point: Daily during the intravenous fluid therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of hyponatremia (plasma sodium concentration of lower than 132 mmol/L); incidence of hypernatremia (plasma sodium concentration of higher than 148 mmol/L); change in weight; change of intravenous fluid regimen; amounts of extra sodium and potassium added to solutions; duration of intravenous fluid therapy. ;Timepoint(s) of evaluation of this end point: Daily during the intravenous fluid therapy. | — |
Countries
Finland
Contacts
Public Contactinvestigator
OYS
Outcome results
None listed