Source:

Kuppermann
N
,
Ghetti
S
,
Schunk
JE
, et al
.
Clinical trial of fluid infusion rates for pediatric diabetic ketoacidosis
.
N Engl J Med
.
2018
;
378
:
2275
2287
; doi:
https://doi.org/10.1056/NEJMoa1716816

Investigators from multiple institutions conducted a randomized controlled trial to assess the effects of rate of administration of IV fluids and sodium chloride (NaCl) content on neurologic outcomes in children presenting with diabetic ketoacidosis (DKA). The study was conducted at 13 ED sites in the Pediatric Emergency Care Applied Research Network. Participants were children 0–18 years old presenting with DKA (defined as a blood glucose >300 mg/dL and either a venous pH <7.25 or serum bicarbonate level <15 mmol/L), and they were randomized using a 2 × 2 factorial design to either fast or slow rehydration with IV fluid that contained either 0.45% or 0.9% NaCl content. All participants received an initial 10 mL/kg IV bolus of 0.9% NaCl fluid. Those randomized to fast rehydration received a second bolus; fluid deficit was calculated as 10% of body weight, which was replaced over 36 hours (one-half over the first 12 hours and the second one-half over the next 24 hours). Children in the slow rehydration group had no additional boluses, fluid deficit was calculated as 5% of body weight, and the deficit was corrected over 48 hours. Glasgow Coma Scale (GCS) scores were assessed hourly over the first 24 hours after admission. Short-term memory was assessed every 4 hours by using forward and backward digit recall tests with standardized scoring. The primary outcome was a GCS score <14. The number of these episodes was calculated for each study child who presented with an initial GCS score >14. Secondary outcomes included scores on the digit recall tests. In addition, the number of children with apparent brain injury, defined as need for hyperosmolar therapy, intubation, or death, was determined. Multiple statistical methods were used to compare outcomes across groups.

A total of 1,255 children with 1,389 episodes of DKA were enrolled in the trial. In 1,361 episodes of DKA in which the patient had an initial GCS score >14, there were 48 episodes in which the GCS score declined to <14 (3.5%), with no differences between groups (slow vs fast rehydration, P=.34; 0.45% vs 0.9% NaCl content, P=.43; interaction, P=.76). There were 12 episodes of clinically apparent brain injury (0.9%); rates varied between 0.6% and 1.4% in the 4 treatment groups, with no significant differences between groups. There were also no statistically significant differences between groups in digit recall scores except for a trend for higher forward recall scores for those randomized to fast rehydration than for children randomized to slow rehydration (P=.06).

The authors conclude that neither IV fluid administration rates nor NaCl content of the fluid influenced neurologic outcomes in children treated for DKA.

Dr Fechner has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative...

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