Clinical trial NCT02926989: Intravenous Fluids in Hospitalised Children
Official title: Fluid Therapy in Acutely Ill Children - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypokalemia
Hyponatremia
Hypernatremia
Dehydration
Keywords: Isotonic
Hypotonic
Intravenous fluids
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2016-10-06
Enrollment: 660
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of children with a clinically significant electrolyte disorder
timeFrame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Secondary outcomes:
measure: Proportion of children with hyponatremia
timeFrame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
measure: Proportion of children with hypernatremia
timeFrame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
measure: Proportion of children with hypokalemia
timeFrame: 0-7 days from study entry
measure: Proportion of children with severe hypokalemia
timeFrame: 0-7 days from study entry
measure: Fluid retention (g) measured by the weight change
timeFrame: 0-7 days: Body weight is measured daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
measure: Concentration of copeptin in plasma samples
timeFrame: 6-24 hours after study entry
measure: Concentration of bicarbonate (HCO3) in plasma samples
timeFrame: 1-3 days after study entry
measure: Acidosis measured by pH in blood gas analysis
timeFrame: 1-3 days after study entry
measure: Alkalosis measured by base excess (BE) in blood gas analysis
timeFrame: 1-3 days after study entry
measure: Duration of intravenous fluid therapy
timeFrame: From randomization up to seven days.
measure: Proportion of children who needed change of the study fluid treatment
timeFrame: From randomization up to seven days.
measure: Proportion of children admitted to ICU
timeFrame: From randomization up to seven days.
measure: Time to discharge from hospital in hours
timeFrame: From randomization up to seven days.
measure: Number of deaths
timeFrame: 0-30 days from study entry
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Terhi Tapiainen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lehtiranta S, Honkila M, Kallio M, Paalanne N, Peltoniemi O, Pokka T, Renko M, Tapiainen T. Risk of Electrolyte Disorders in Acutely Ill Children Receiving Commercially Available Plasmalike Isotonic Fluids: A Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):28-35. doi: 10.1001/jamapediatrics.2020.3383.