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

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

Randomized, Controlled, Double Blinded, Clinical Trial: 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children

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.

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

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

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).

HOLLIDAY MA, SEGAR WE, LUKENBILL A, VALENCIA RM, DURELL AM. Variations in muscle electrolyte composition due to sampling and to aging. Proc Soc Exp Biol Med. 1957 Aug-Sep;95(4):786-8. doi: 10.3181/00379727-95-23364. No abstract available.

Burrows FA, Shutack JG, Crone RK. Inappropriate secretion of antidiuretic hormone in a postsurgical pediatric population. Crit Care Med. 1983 Jul;11(7):527-31. doi: 10.1097/00003246-198307000-00009.

Eulmesekian PG, Perez A, Minces PG, Bohn D. Hospital-acquired hyponatremia in postoperative pediatric patients: prospective observational study. Pediatr Crit Care Med. 2010 Jul;11(4):479-83. doi: 10.1097/PCC.0b013e3181ce7154.

Choong K, Kho ME, Menon K, Bohn D. Hypotonic versus isotonic saline in hospitalised children: a systematic review. Arch Dis Child. 2006 Oct;91(10):828-35. doi: 10.1136/adc.2005.088690. Epub 2006 Jun 5.

Jorro Baron FA, Meregalli CN, Rombola VA, Bolasell C, Pigliapoco VE, Bartoletti SE, Debaisi GE. Hypotonic versus isotonic maintenance fluids in critically ill pediatric patients: a randomized controlled trial. Arch Argent Pediatr. 2013 Jul-Aug;111(4):281-7. doi: 10.5546/aap.2013.eng.281. English, Spanish.