Intravenous Fluids in Hospitalised Children

Dehydration Clinical Trial

Official title:

Fluid Therapy in Acutely Ill Children - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926989
• Other study ID #: EETTMK 48/2016
• Status: Completed
• Phase: Phase 4
• Start date: October 3, 2016
• Est. completion date: April 15, 2019

Study information

• Verified date: August 2019
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: April 15, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Dehydration
• Hypernatremia
• Hypokalemia
• Hyponatremia

Intervention

Drug:
• Plasmalyte Glucos 50 mg/mL
Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.
• 0.45% saline in 5% dextrose
Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Proportion of children with hypokalemia	Potassium < 3.5 mmol/L	0-7 days from study entry
Secondary	Proportion of children with severe hypokalemia	Hypokalemia defined as concentration of potassium <3.0 mmol/L	0-7 days from study entry
Secondary	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.
Secondary	Concentration of copeptin in plasma samples	Copeptin plasma concentration	6-24 hours after study entry
Secondary	Concentration of bicarbonate (HCO3) in plasma samples	Plasma concentration of bicarbonate HCO3	1-3 days after study entry
Secondary	Acidosis measured by pH in blood gas analysis	pH in the blood gas analysis	1-3 days after study entry
Secondary	Alkalosis measured by base excess (BE) in blood gas analysis	Base excess in the blood gas analysis	1-3 days after study entry
Secondary	Duration of intravenous fluid therapy	Hours from study entry to the stop of fluid therapy	From randomization up to seven days.
Secondary	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.
Secondary	Proportion of children admitted to ICU	Admission to ICU for any reason	From randomization up to seven days.
Secondary	Time to discharge from hospital in hours	Time from study entry to discharge in hours	From randomization up to seven days.
Secondary	Number of deaths	Any death during the study	0-30 days from study entry