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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02926989
Other study ID # EETTMK 48/2016
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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