Intravenous fluids in hospitalised children - a randomised controlled trial

Phase 1

Conditions: Acutely ill hospitalised children who need intravenous fluid therapy.
Therapeutic area: Body processes [G] - Physiological processes [G07]

Registration Number: EUCTR2016-002046-23-FI

Lead Sponsor: Minna Honkila / OYS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.