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Intravenous Fluids in Hospitalised Children

Primary Purpose

Hypokalemia, Hyponatremia, Hypernatremia

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Plasmalyte Glucos 50 mg/mL
0.45% saline in 5% dextrose
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypokalemia focused on measuring Isotonic, Hypotonic, Intravenous fluids

Eligibility Criteria

6 Months - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Isotonic solution

Hypotonic solution

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of children with hyponatremia
Plasma sodium concentration of lower than 132 mmol/L.
Proportion of children with hypernatremia
Plasma sodium concentration of higher than 148 mmol/L.
Proportion of children with hypokalemia
Potassium < 3.5 mmol/L
Proportion of children with severe hypokalemia
Hypokalemia defined as concentration of potassium <3.0 mmol/L
Fluid retention (g) measured by the weight change
Weight (g) at discharge - weight (g) at admission
Concentration of copeptin in plasma samples
Copeptin plasma concentration
Concentration of bicarbonate (HCO3) in plasma samples
Plasma concentration of bicarbonate HCO3
Acidosis measured by pH in blood gas analysis
pH in the blood gas analysis
Alkalosis measured by base excess (BE) in blood gas analysis
Base excess in the blood gas analysis
Duration of intravenous fluid therapy
Hours from study entry to the stop of fluid therapy
Proportion of children who needed change of the study fluid treatment
Any change of the fluid used in the treatment
Proportion of children admitted to ICU
Admission to ICU for any reason
Time to discharge from hospital in hours
Time from study entry to discharge in hours
Number of deaths
Any death during the study

Full Information

First Posted
October 4, 2016
Last Updated
August 20, 2019
Sponsor
University of Oulu
Collaborators
Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02926989
Brief Title
Intravenous Fluids in Hospitalised Children
Official Title
Fluid Therapy in Acutely Ill Children - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
Collaborators
Oulu University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypokalemia, Hyponatremia, Hypernatremia, Dehydration
Keywords
Isotonic, Hypotonic, Intravenous fluids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isotonic solution
Arm Type
Experimental
Arm Description
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.
Arm Title
Hypotonic solution
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Plasmalyte Glucos 50 mg/mL
Other Intervention Name(s)
ATC-code: B05BB02
Intervention Description
Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.
Intervention Type
Drug
Intervention Name(s)
0.45% saline in 5% dextrose
Other Intervention Name(s)
0.45% NaCl in 5% dextrose.
Intervention Description
Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.
Primary Outcome Measure Information:
Title
Proportion of children with a clinically significant electrolyte disorder
Description
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.
Secondary Outcome Measure Information:
Title
Proportion of children with hyponatremia
Description
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.
Title
Proportion of children with hypernatremia
Description
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.
Title
Proportion of children with hypokalemia
Description
Potassium < 3.5 mmol/L
Time Frame
0-7 days from study entry
Title
Proportion of children with severe hypokalemia
Description
Hypokalemia defined as concentration of potassium <3.0 mmol/L
Time Frame
0-7 days from study entry
Title
Fluid retention (g) measured by the weight change
Description
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.
Title
Concentration of copeptin in plasma samples
Description
Copeptin plasma concentration
Time Frame
6-24 hours after study entry
Title
Concentration of bicarbonate (HCO3) in plasma samples
Description
Plasma concentration of bicarbonate HCO3
Time Frame
1-3 days after study entry
Title
Acidosis measured by pH in blood gas analysis
Description
pH in the blood gas analysis
Time Frame
1-3 days after study entry
Title
Alkalosis measured by base excess (BE) in blood gas analysis
Description
Base excess in the blood gas analysis
Time Frame
1-3 days after study entry
Title
Duration of intravenous fluid therapy
Description
Hours from study entry to the stop of fluid therapy
Time Frame
From randomization up to seven days.
Title
Proportion of children who needed change of the study fluid treatment
Description
Any change of the fluid used in the treatment
Time Frame
From randomization up to seven days.
Title
Proportion of children admitted to ICU
Description
Admission to ICU for any reason
Time Frame
From randomization up to seven days.
Title
Time to discharge from hospital in hours
Description
Time from study entry to discharge in hours
Time Frame
From randomization up to seven days.
Title
Number of deaths
Description
Any death during the study
Time Frame
0-30 days from study entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terhi Tapiainen, MD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33104176
Citation
Lehtiranta S, Honkila M, Kallio M, Paalanne N, Peltoniemi O, Pokka T, Renko M, Tapiainen T. Risk of Electrolyte Disorders in Acutely Ill Children Receiving Commercially Available Plasmalike Isotonic Fluids: A Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):28-35. doi: 10.1001/jamapediatrics.2020.3383. Erratum In: JAMA Pediatr. 2021 Feb 1;175(2):212.
Results Reference
derived

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Intravenous Fluids in Hospitalised Children

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