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Randomized Controlled Trial
©Author(s) (or their employer(s)) 2026. No commercial re-use. See Permissions. Published by Baishideng Publishing Group Inc.
World J Clin Pediatr. Mar 9, 2026; 15(1): 111304
Published online Mar 9, 2026. doi: 10.5409/wjcp.v15.i1.111304
Balanced electrolyte solution vs isotonic saline in the resuscitation of children with diabetic ketoacidosis: A randomized controlled trial
Sweta Sweety, Swarupa Panda, Rashmi Ranjan Das
Sweta Sweety, Swarupa Panda, Department of Pediatrics, Srirama Chandra Bhanja Medical College, Cuttack 753007, Odisha, India
Rashmi Ranjan Das, Department of Pediatrics, All India Institute of Medical Sciences, Bhubaneswar 751019, Odisha, India
Author contributions: Sweety S, Panda S, and Das RR contributed to conceptualization and design; Sweety S, Panda S contributed to material preparation, and data acquisition; Sweety S, and Das RR contributed to data analysis; all authors contributed to writing-draft manuscript and writing-revision and approved to submit the final version.
Institutional review board statement: The study was reviewed and approved by the Institute Ethics Committee, SCB Medical College and Hospital, Cuttack (Approval No. 1567).
Informed consent statement: All study participants, or their legal guardians, provided written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement for randomized controlled trials.
Data sharing statement: There is no additional data available.
Corresponding author: Rashmi R Das, FCCP, MD, Professor, Department of Pediatrics, All India Institute of Medical Sciences, Sijua, Bhubaneswar 751019, Odisha, India. ped_rashmi@aiimsbhubaneswar.edu.in
Received: July 1, 2025
Revised: July 24, 2025
Accepted: October 29, 2025
Published online: March 9, 2026
Processing time: 252 Days and 14 Hours
Abstract
BACKGROUND

Fluid therapy is a cornerstone in the management of diabetic ketoacidosis (DKA). Normal saline (NS, 0.9%) has traditionally been the fluid of choice; however, concerns about its association with hyperchloremic metabolic acidosis and possible development of acute kidney injury (AKI) have led to an increased interest in balanced electrolyte solutions (BES) as a potentially safer alternative.

AIM

To compare BES with NS in the initial resuscitation of children with DKA.

METHODS

This double-blind, parallel, randomized controlled trial (RCT) was conducted in the Pediatrics department of a tertiary care teaching hospital over two-year period. Children aged 5 to 14 years with DKA as defined by the “International Society for Pediatric and Adolescent Diabetes” were included. The primary objective was-the time taken to resolution of acidosis. Secondary objectives were-effect on electrolyte imbalances, development of cerebral edema or AKI, and other clinical outcomes.

RESULTS

Sixty patients were enrolled. The mean (SD) age of the patients was 10.7 (1.42) years, and majority were female (73.3%). The time (hour) taken for resolution of acidosis was not significantly different (P = 0.16). The NS group had a higher incidence of hyperchloremia (P = 0.09), AKI (P = 0.07), and prolonged hospitalization (P = 0.23), but all these were not statistically significant. Other outcomes were comparable in both the groups.

CONCLUSION

This trial did not find any significant difference between BES and NS (0.9%) in the initial resuscitation of children with DKA.

Keywords: Crystalloids; Hyperglycemia; Hyperchloremia; Acidosis; Acute kidney injury

Core Tip: The management of childhood diabetic keto-acidosis (DKA) is fluid resuscitation in addition to insulin infusion. There is a controversy regarding the ideal fluid for the management of DKA. This trial compared balanced electrolyte solution (BES) with normal saline (NS), and found no difference between the two. However, a trend towards lower complication rate was noted with BES. BES might be preferred over NS for initial management of children with DKA where resource constraint is not an issue.