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

Hospital General de Niños Pedro de Elizalde

Status

Completed

Conditions

Hyponatremia

Treatments

Drug: hypotonic

Drug: isotonic

Study type

Interventional

Funder types

Other

Identifiers

NCT01301274

HGNPE-20-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

1 month to 18 years old

Volunteers

No Healthy Volunteers

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).