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

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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).

Arm && Interventions

Group	Intervention	Description
Hypotonic	hypotonic	Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
Isotonic	isotonic	Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.

Primary Outcome Measures

Name	Time	Method
Serum Sodium Levels in Both Groups	first 48 hours	Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion

Secondary Outcome Measures

Name	Time	Method
Mortality at 28 Days	28 days after admission	Mortality in both groups will be compared 28 days after admission
Mechanical Ventilation Free Days at 28 Day of Admission	first 28 day after starting mechanical ventilation	mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero.
ICU Length of Stay	180 days	ICU length of stay (in days)