XXXX Intravenous Maintenance Fluids: A Randomized Clinical Trial.

@entity1 @entity101 @entity4 @entity3489 @entity1372 @entity2753 @entity2421 @entity1017 @entity2827 @entity413
Importance: Use of @entity2421 intravenous fluids for maintenance requirements is associated with increased risk of @entity2753 that results in morbidity and mortality in @entity1 . Clinical trial data comparing isotonic and @entity2421 maintenance fluids in nonsurgical hospitalized pediatric @entity1 outside intensive care units are lacking. Objective: To compare isotonic ( @entity2827 , 0.9%, and @entity413 , 5%) with @entity2421 ( @entity2827 , 0.45%, and @entity413 , 5%) intravenous maintenance fluids in a hospitalized general pediatric population. Design, Setting, and @entity1 : In this double-blind randomized clinical trial,we recruited 110 @entity1 admitted to a general pediatric unit of a tertiary care @entity1 's hospital from March 1, 2008, through August 31, 2012 (age range, 1 month to 18 years), with normal baseline serum @entity1372 levels who were anticipated to require intravenous maintenance fluids for 48 hours or longer (intent-to-treat analyses). @entity1 with diagnoses that required specific fluid tonicity and volumes were excluded. Interventions: @entity1 were randomized to receive isotonic or @entity2421 intravenous fluid at maintenance rates for 48 hours. Main Outcomes and Measures: The primary outcome was mean serum @entity1372 level at 48 hours. The secondary outcomes were mean @entity1372 level at 24 hours, @entity2753 and @entity3489 , @entity1017 , @entity101 , and @entity4 . Confounding variables were included in multiple regression models. Post hoc analyses included change from baseline @entity1372 level at 24 and 48 hours and subgroup analysis of @entity1 with primary respiratory diagnosis. Results: Of 110 enrolled @entity1 , 54 received isotonic fluids and 56 received @entity2421 fluids. The mean (SD) @entity1372 level at 48 hours was 139.9   (2.7) mEq/L in the isotonic group and 139.6   (2.6) mEq/L in the @entity2421 group (95% CI of the difference, -0.94 to 1.74 mEq/L; P   =   .60). Two @entity1 in the @entity2421 group developed @entity2753 , 1 in each group developed @entity3489 , 2 in each group developed @entity101 , and 2 in the isotonic group developed @entity4 . Mean (SD) change from baseline to 48-hour @entity1372 level was +1.3   (2.9) vs -0.12   (2.8) mEq/L, respectively (absolute difference, 1.4 mEq/L; 95% CI of the difference, -0.01 to 2.8 mEq/L; P   =   .05). Conclusions and Relevance: Our study results support the notion that isotonic maintenance fluid administration is safe in general pediatric @entity1 and may result in fewer cases of @entity2753 . Trial Registration: clinicaltrials.gov Identifier: NCT00632775.
