Intravenous Fluids in Hospitalised Children

NCT02926989 | Completed Phase 4

• 1 other identifier: EETTMK 48/2016
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypokalemia; Hyponatremia; Hypernatremia; Dehydration

Keywords

Isotonic; Hypotonic; Intravenous fluids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Proportion of children with hyponatremia

  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 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

  0-7 days from study entry

• Proportion of children with severe hypokalemia

  0-7 days from study entry

• Fluid retention (g) measured by the weight change

  0-7 days: Body weight is measured daily (at 7 am) during the intravenous fluid therapy from randomization up to seven days.

Study Arms (2)

Isotonic solution

EXPERIMENTAL

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

Hypotonic solution

ACTIVE COMPARATOR

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

Interventions

Plasmalyte Glucos 50 mg/mL DRUG

Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.

Also known as: ATC-code: B05BB02

Isotonic solution

0.45% saline in 5% dextrose DRUG

Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.

Also known as: 0.45% NaCl in 5% dextrose.

Hypotonic solution

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Acutely ill hospitalised children
• Need for intravenous fluid therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead
• Oulu University Hospital: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, 90029, Finland

Location

Related Publications (1)

• 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.

  PMID: 33104176 DERIVED

MeSH Terms

Conditions

Hypokalemia; Hyponatremia; Hypernatremia; Dehydration

Interventions

Sodium Chloride; Glucose

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Terhi Tapiainen, MD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 6, 2016
• Study Start: October 3, 2016
• Primary Completion: March 31, 2019
• Study Completion: April 15, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)