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

Hospital General de Niños Pedro de Elizalde66 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hyponatremia

Interventions

hypotonicDRUG

0.45% NaCl/5% dextrose IV maintenance fluids

isotonicDRUG

0.9% NaCl/5% dextrose IV maintenance fluids

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Hospital General de Niños Pedro de Elizalde

Buenos Aires, Argentina

Outcomes

Primary Outcomes

Serum Sodium Levels in Both Groups

Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion

Time frame: first 48 hours

Secondary Outcomes

Mortality at 28 Days

Mortality in both groups will be compared 28 days after admission

Time frame: 28 days after admission

Mechanical Ventilation Free Days at 28 Day of Admission

mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero.

Time frame: first 28 day after starting mechanical ventilation

ICU Length of Stay

ICU length of stay (in days)

Time frame: 180 days

Data from ClinicalTrials.gov

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