0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-11-30

Brief Summary

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The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration.

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Detailed Description

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In patients without possibilities of oral intake, maintenance fluids provide electrolytes and water. Since the original descriptions by Holliday and Segar, the recommended standard maintenance solutions are based on "physiological needs", containing 30-50 mEq/L of sodium.

However hyponatremia has become increasingly recognized in hospitalized children suggesting that Holliday and Segar's recommendations are frequently inappropriately applied.

It has been described augmented intersticial lung water in patients receiving hypotonic maintenance solutions. Also, hyponatremia has been demonstrated in post-surgery critically ill children receiving hypotonic maintenance solutions.

More over, non-physiologic antidiuretic hormone (ADH) secretion has been described in the great majority of hospitalized children due to nausea, stress, pain, and/or surgical interventions.

It has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance intravenous (IV) solution, to avoid the development of hyponatremia.

There are not studies in critically ill children evaluating the effect of isotonic solutions on sodium levels.

Conditions

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Hyponatremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hypotonic

Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.

Group Type ACTIVE_COMPARATOR

hypotonic

Intervention Type DRUG

0.45% NaCl/5% dextrose IV maintenance fluids

Isotonic

Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.

Group Type EXPERIMENTAL

isotonic

Intervention Type DRUG

0.9% NaCl/5% dextrose IV maintenance fluids

Interventions

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hypotonic

0.45% NaCl/5% dextrose IV maintenance fluids

Intervention Type DRUG

isotonic

0.9% NaCl/5% dextrose IV maintenance fluids

Intervention Type DRUG

Other Intervention Names

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half saline/5% dextrose normal saline/5% dextrose

Eligibility Criteria

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Inclusion Criteria

* Age 1 month to 18 years
* ICU stay \>24 hours
* Normal seric sodium (135 - 145 mEq/L).
* Requirement of IV maintenance solutions \>80% total fluids intake

Exclusion Criteria

* Patients with diagnoses of renal failure (serum creatinine \>1 g/dl in \<3 years old children, \>1,5 in \>3 years), hepatic failure with ascitis and portal hypertension, adrenal failure, nephrotic - nephritic syndrome, Kawasaki disease, sickle cell anemia, Syndrome of inappropriate antidiuretic hormone secretion, diabetes insipidus,metabolic disease.
* Diuretics use in the first 48 hours thereafter indicated IV solutions.
* Plasma glucose is \>200 mg%.
* Any patients requiring IV fluids therapy different that maintenance (total parenteral nutrition, hyperhydration).

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No