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Completed

NCT Number: NCT02926989

Intravenous Fluids in Hospitalised Children

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.

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Key information

Conditions

Hypokalemia Dehydration Hypernatremia Hyponatremia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oulu University Hospital

Oulu, 90029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasmalyte Glucos 50 mg/mL

Drug

Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.

Other names: ATC-code: B05BB02

0.45% Saline in 5% dextrose

Drug

Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.

Other names: 0.45% NaCl in 5% dextrose.

Primary outcomes

  1. Proportion of children with a clinically significant electrolyte disorder

    Time frame: 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 outcomes

  1. Proportion of children with hyponatremia

    Time frame: 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.

  2. Proportion of children with hypernatremia

    Time frame: 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.

  3. Proportion of children with hypokalemia

    Time frame: 0-7 days from study entry

    Potassium < 3.5 mmol/L

  4. Proportion of children with severe hypokalemia

    Time frame: 0-7 days from study entry

    Hypokalemia defined as concentration of potassium <3.0 mmol/L

  5. Fluid retention (g) measured by the weight change

    Time frame: 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

  6. Concentration of copeptin in plasma samples

    Time frame: 6-24 hours after study entry

    Copeptin plasma concentration

  7. Concentration of bicarbonate (HCO3) in plasma samples

    Time frame: 1-3 days after study entry

    Plasma concentration of bicarbonate HCO3

  8. Acidosis measured by pH in blood gas analysis

    Time frame: 1-3 days after study entry

    pH in the blood gas analysis

  9. Alkalosis measured by base excess (BE) in blood gas analysis

    Time frame: 1-3 days after study entry

    Base excess in the blood gas analysis

  10. Duration of intravenous fluid therapy

    Time frame: From randomization up to seven days.

    Hours from study entry to the stop of fluid therapy

  11. Proportion of children who needed change of the study fluid treatment

    Time frame: From randomization up to seven days.

    Any change of the fluid used in the treatment

  12. Proportion of children admitted to ICU

    Time frame: From randomization up to seven days.

    Admission to ICU for any reason

  13. Time to discharge from hospital in hours

    Time frame: From randomization up to seven days.

    Time from study entry to discharge in hours

  14. Number of deaths

    Time frame: 0-30 days from study entry

    Any death during the study

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Oulu University Hospital

Registry information

Official study title

Fluid Therapy in Acutely Ill Children - a Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 6, 2016
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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