Intravenous Fluids in Hospitalised Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-03

Study Completion Date

2019-04-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypokalemia Hyponatremia Hypernatremia Dehydration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Plasmalyte Glucos 50 mg/mL

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

0.45% saline in 5% dextrose

Intervention Type DRUG

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

Interventions

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Plasmalyte Glucos 50 mg/mL

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

Intervention Type DRUG

0.45% saline in 5% dextrose

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

Intervention Type DRUG

Other Intervention Names

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ATC-code: B05BB02 0.45% NaCl in 5% dextrose.

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes