A Phase 4 interventional study of Plasmalyte Glucos 50 mg/mL and 0.45% saline in 5% dextrose in Hypokalemia, Hyponatremia and Hypernatremia, sponsored by University of Oulu. Completed at 1 site in Finland. Open to participants aged 6 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-22.
Sponsored by University of Oulu · Phase 4, Interventional, and Treatment
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.
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.
38 studies on the registry are indexed under Hypokalemia; 5 are open to participants now.
This study's enrollment of 660 is above the median of 77 across 29 interventional studies indexed under Hypokalemia.
Browse Hypokalemia studies →University of Oulu is the lead sponsor of 141 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Plasmalyte Glucos 50 mg/mL; total daily fluid requirements are estimated using the Holiday-Segar method plus possible dehydration (according to child's weight loss during acute illness); intravenous fluids are administered using delivery pumps programmed for an hourly infusion rate (mL/hour); intravenous fluids are administered as long as needed during hospitalization, but no longer than seven days after admission.
Drug: Plasmalyte Glucos 50 mg/mL
0.45% saline in 5% dextrose; total daily fluid requirements are estimated using the Holiday-Segar method plus possible dehydration (according to child's weight loss during acute illness); intravenous fluids are administered using delivery pumps programmed for an hourly infusion rate (mL/hour); intravenous fluids are administered as long as needed during hospitalization, but no longer than seven days after admission.
Drug: 0.45% saline in 5% dextrose
Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.
Also known as: ATC-code: B05BB02
Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.
Also known as: 0.45% NaCl in 5% dextrose.
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
Time frame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Proportion of children with hyponatremia
Plasma sodium concentration of lower than 132 mmol/L.
Time frame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Proportion of children with hypernatremia
Plasma sodium concentration of higher than 148 mmol/L.
Time frame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Proportion of children with hypokalemia
Potassium \< 3.5 mmol/L
Time frame: 0-7 days from study entry
Proportion of children with severe hypokalemia
Hypokalemia defined as concentration of potassium \<3.0 mmol/L
Time frame: 0-7 days from study entry
Fluid retention (g) measured by the weight change
Weight (g) at discharge - weight (g) at admission
Time frame: 0-7 days: Body weight is measured daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.
Concentration of copeptin in plasma samples
Copeptin plasma concentration
Time frame: 6-24 hours after study entry
Concentration of bicarbonate (HCO3) in plasma samples
Plasma concentration of bicarbonate HCO3
Time frame: 1-3 days after study entry
Acidosis measured by pH in blood gas analysis
pH in the blood gas analysis
Time frame: 1-3 days after study entry
Alkalosis measured by base excess (BE) in blood gas analysis
Base excess in the blood gas analysis
Time frame: 1-3 days after study entry
Duration of intravenous fluid therapy
Hours from study entry to the stop of fluid therapy
Time frame: From randomization up to seven days.
Proportion of children who needed change of the study fluid treatment
Any change of the fluid used in the treatment
Time frame: From randomization up to seven days.
Proportion of children admitted to ICU
Admission to ICU for any reason
Time frame: From randomization up to seven days.
Time to discharge from hospital in hours
Time from study entry to discharge in hours
Time frame: From randomization up to seven days.
Number of deaths
Any death during the study
Time frame: 0-30 days from study entry
Plan to share: No
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.