Intravenous Fluids in Hospitalised Children

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02926989
• Date of registration: 04/10/2016
• Prospective Registration: No
• Primary sponsor: University of Oulu
• Public title: Intravenous Fluids in Hospitalised Children
• Scientific title: Fluid Therapy in Acutely Ill Children - a Randomized Controlled Trial
• Date of first enrolment: October 3, 2016
• Target sample size: 660
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02926989
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Finland

Contacts

• Name: Terhi Tapiainen, MD
• Affiliation: Oulu University Hospital

Key inclusion & exclusion 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



Age minimum: 6 Months
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypernatremia

Hyponatremia

Dehydration

Hypokalemia

Intervention(s)

Drug: Plasmalyte Glucos 50 mg/mL

Drug: 0.45% saline in 5% dextrose

Primary Outcome(s)

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.]

Secondary Outcome(s)

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.]

Proportion of children who needed change of the study fluid treatment [Time Frame: From randomization up to seven days.]

Alkalosis measured by base excess (BE) in blood gas analysis [Time Frame: 1-3 days after study entry]

Concentration of copeptin in plasma samples [Time Frame: 6-24 hours after study entry]

Proportion of children with hypokalemia [Time Frame: 0-7 days from study entry]

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.]

Number of deaths [Time Frame: 0-30 days from study entry]

Acidosis measured by pH in blood gas analysis [Time Frame: 1-3 days after study entry]

Duration of intravenous fluid therapy [Time Frame: From randomization up to seven days.]

Proportion of children with severe hypokalemia [Time Frame: 0-7 days from study entry]

Concentration of bicarbonate (HCO3) in plasma samples [Time Frame: 1-3 days after study entry]

Proportion of children admitted to ICU [Time Frame: From randomization up to seven days.]

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.]

Time to discharge from hospital in hours [Time Frame: From randomization up to seven days.]

Secondary ID(s)

EETTMK 48/2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oulu University Hospital