Clinical Trial: Intravenous Fluids in Hospitalised Children

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Isotonic Versus Hypotonic Intravenous Fluids in Hospitalised Children - a Randomised Controlled Trial

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 Summary: 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.
Sponsor: University of Oulu

Current Primary Outcome: Incidence of hypokalemia [ Time Frame: Plasma sodium and potassium concentrations are assessed daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days. ]

Plasma potassium concentration of lower than 3.5 mmol/L.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of 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. ]
    Plasma sodium concentration of lower than 132 mmol/L.
  • Incidence of 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. ]
    Plasma sodium concentration of higher than 148 mmol/L.
  • Change in weight [ Time Frame: Body weight is measured daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days. ]
  • Change of intravenous fluid regimen [ Time Frame: From randomization up to seven days. ]
  • Amounts of extra sodium and potassium added to solutions [ Time Frame: From randomization up to seven days. ]
  • Duration of intravenous fluid therapy [ Time Frame: From randomization up to seven days. ]
  • Admission to ICU [ Time Frame: From randomization up to seven days. ]
  • Time to discharge [ Time Frame: From randomization up to seven days. ]


Original Secondary Outcome: Same as current

Information By: University of Oulu

Dates:
Date Received: October 4, 2016
Date Started: October 2016
Date Completion: December 2018
Last Updated: October 5, 2016
Last Verified: October 2016