Intravenous Fluids in Hospitalised Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fluid Therapy in Acutely Ill Children - a Randomized Controlled Trial

Conditions
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Hypokalemia, Hyponatremia, Hypernatremia, Dehydration

Intervention / Treatment
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* Drug: Plasmalyte Glucos 50 mg/mL
* Drug: 0.45% saline in 5% dextrose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isotonic solution<br>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. | Drug: Plasmalyte Glucos 50 mg/mL<br>* Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.<br>* Other names: ATC-code: B05BB02;|
| Active Comparator: Hypotonic solution<br>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. | Drug: 0.45% saline in 5% dextrose<br>* Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.<br>* Other names: 0.45% NaCl in 5% dextrose.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of children with hyponatremia | Plasma sodium concentration of lower than 132 mmol/L. | 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. | 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 | 0-7 days from study entry | 
| Proportion of children with severe hypokalemia | Hypokalemia defined as concentration of potassium <3.0 mmol/L | 0-7 days from study entry | 
| Fluid retention (g) measured by the weight change | Weight (g) at discharge - weight (g) at admission | 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 | Copeptin plasma concentration | 6-24 hours after study entry | 
| Concentration of bicarbonate (HCO3) in plasma samples | Plasma concentration of bicarbonate HCO3 | 1-3 days after study entry | 
| Acidosis measured by pH in blood gas analysis | pH in the blood gas analysis | 1-3 days after study entry | 
| Alkalosis measured by base excess (BE) in blood gas analysis | Base excess in the blood gas analysis | 1-3 days after study entry | 
| Duration of intravenous fluid therapy | Hours from study entry to the stop of fluid therapy | From randomization up to seven days. | 
| Proportion of children who needed change of the study fluid treatment | Any change of the fluid used in the treatment | From randomization up to seven days. | 
| Proportion of children admitted to ICU | Admission to ICU for any reason | From randomization up to seven days. | 
| Time to discharge from hospital in hours | Time from study entry to discharge in hours | From randomization up to seven days. | 
| Number of deaths | Any death during the study | 0-30 days from study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Isotonic, Hypotonic, Intravenous fluids