Intravenous Fluids in Hospitalised Children
- Conditions
- DehydrationHypokalemiaHyponatremiaHypernatremia
- Interventions
- Drug: Plasmalyte Glucos 50 mg/mLDrug: 0.45% saline in 5% dextrose
- Registration Number
- NCT02926989
- Lead Sponsor
- University of Oulu
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 660
- Acutely ill hospitalised children
- Need for intravenous fluid therapy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Isotonic solution Plasmalyte Glucos 50 mg/mL 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. Hypotonic solution 0.45% saline in 5% dextrose 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Concentration of bicarbonate (HCO3) in plasma samples 1-3 days after study entry Plasma concentration of bicarbonate HCO3
Alkalosis measured by base excess (BE) in blood gas analysis 1-3 days after study entry Base excess in the blood gas analysis
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
Proportion of children with severe hypokalemia 0-7 days from study entry Hypokalemia defined as concentration of potassium \<3.0 mmol/L
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.
Concentration of copeptin in plasma samples 6-24 hours after study entry Copeptin plasma concentration
Proportion of children with hypokalemia 0-7 days from study entry Potassium \< 3.5 mmol/L
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.
Acidosis measured by pH in blood gas analysis 1-3 days after study entry pH in the blood gas analysis
Number of deaths 0-30 days from study entry Any death during the study
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
Duration of intravenous fluid therapy From randomization up to seven days. Hours from study entry to the stop of fluid therapy
Trial Locations
- Locations (1)
Oulu University Hospital
🇫🇮Oulu, Finland