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Intravenous Fluids in Hospitalised Children

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ClinicalTrials.gov Identifier: NCT02926989
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
Terhi Tapiainen, University of Oulu

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.

Condition or disease Intervention/treatment Phase
Hypokalemia Hyponatremia Hypernatremia Dehydration Drug: Plasmalyte Glucos 50 mg/mL Drug: 0.45% saline in 5% dextrose Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Isotonic Versus Hypotonic Intravenous Fluids in Hospitalised Children - a Randomised Controlled Trial
Actual Study Start Date : October 3, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: Isotonic solution
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
Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.
Other Name: ATC-code: B05BB02

Active Comparator: Hypotonic solution
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 20 mmol/L and sodium chloride 80 mmol/L.
Other Name: 0.45% NaCl in 5% dextrose.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in weight [ Time Frame: Body weight is measured daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days. ]
  4. Change of intravenous fluid regimen [ Time Frame: From randomization up to seven days. ]
  5. Amounts of extra sodium and potassium added to solutions [ Time Frame: From randomization up to seven days. ]
  6. Duration of intravenous fluid therapy [ Time Frame: From randomization up to seven days. ]
  7. Admission to ICU [ Time Frame: From randomization up to seven days. ]
  8. Time to discharge [ Time Frame: From randomization up to seven days. ]


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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926989


Contacts
Contact: Minna Honkila, MD +35883155863 minna.honkila@ppshp.fi
Contact: Terhi Tapiainen, MD PhD +35883155185 terhi.tapiainen@oulu.fi

Locations
Finland
Oulu University Hospital Recruiting
Oulu, Finland, 90029
Contact: Minna Honkila, MD    +35883155863    minna.honkila@ppshp.fi   
Contact: Terhi Tapiainen, MD PhD    +35883155185    terhi.tapiainen@oulu.fi   
Sub-Investigator: Saara Lehtiranta, MD         
Sub-Investigator: Merja Kallio, MD PhD         
Sub-Investigator: Niko Paalanne, MD PhD         
Sub-Investigator: Outi Peltoniemi, MD PhD         
Sub-Investigator: Tytti Pokka, MSc         
Sub-Investigator: Hannele Pruikkonen, MD PhD         
Sub-Investigator: Marjo Renko, MD PhD         
Principal Investigator: Minna Honkila, MD         
Principal Investigator: Terhi Tapiainen, MD PhD         
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Investigators
Principal Investigator: Terhi Tapiainen, MD Oulu University Hospital

Responsible Party: Terhi Tapiainen, Adjunct professor, University of Oulu
ClinicalTrials.gov Identifier: NCT02926989     History of Changes
Other Study ID Numbers: EETTMK 48/2016
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Terhi Tapiainen, University of Oulu:
Isotonic
Hypotonic
Intravenous fluids

Additional relevant MeSH terms:
Hypokalemia
Potassium Deficiency
Hyponatremia
Dehydration
Hypernatremia
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Deficiency Diseases
Malnutrition
Nutrition Disorders
Plasma-lyte 148
Pharmaceutical Solutions
Ophthalmic Solutions