Hypotonic and isotonic intravenous maintenance fluids in hospitalised paediatric patients: a randomised controlled trial

OBJECTIVE: To compare the changes in serum sodium and acid/base status in patients receiving hypotonic and isotonic solutions. DESIGN: A randomised, controlled and double-blind clinical trial. SETTING: Department of Paediatrics in a tertiary general hospital (Hospital Universitario Austral) in Buenos Aires, Argentina. PATIENTS: Children between 29 days and 15 years of age who were hospitalised in the paediatric intensive care unit and general hospital between 12 January 2010 and 30 November 2016, and who required exclusively parenteral maintenance solutions for at least 24 hours. INTERVENTIONS: A hypotonic solution with 77 mEq/L sodium chloride (0.45% in 5% dextrose) and isotonic solution with 150 mEq/L (0.9% in 5% dextrose) were infused for 48 hours and were labelled. MAIN OUTCOME MEASURE: The main outcome was to evaluate the incidence of hyponatraemia between patients treated with parenteral hydration with hypotonic or isotonic fluids. The secondary outcome was to estimate the incidence of metabolic acidosis induced by each of the solutions. RESULTS: The 299 patients in the present study were randomised to groups that received the hypotonic solution (n=154) or isotonic solution (n=145). The mean serum sodium concentration measurements at 12 hours were 136.3±3.9 mEq/L and 140.1±2.3 mEq/L in the hypotonic and isotonic groups, respectively, with a hyponatraemia incidence of 8.27% (n=12) and 18.8% (n=29) (p<0.001). At 24 hours, 12.4% (n=18) of the isotonic group had developed hyponatraemia compared with 46.1% (n=71) of the hypotonic group (p<0.001). The mean serum sodium concentration measurements were 134.4±5.6 and 139.3±3.1, respectively. No patient developed hypernatraemia (serum sodium concentrations >150 mEq/L) or other adverse outcomes. The relative risk in the hypotonic group was 3.7 (95% CI 2.3 to 5.9), almost four times the risk of developing hyponatraemia than those who received isotonic fluids. There were also no significant differences between the groups with regard to the development of metabolic acidosis. Hypotonic solution, age <12 months and postoperative abdominal surgery were risk factors associated with hyponatraemia. CONCLUSIONS: The incidence of iatrogenic hyponatraemia was greater with the administration of hypotonic fluids compared with that of isotonic fluids. There were no significant differences in the incidence of metabolic acidosis between the groups.