Design

Randomized controlled trial (unblinded)

Inclusion

• 0 to 18 years of age
• dx of DKA, defined as glucose >300 mg/dL and either pH <7.25 or HCO3 <15 mmol/L

Key exclusion

• Pts with initial GCS <12 (due to physician reluctance to include these patients)

Treatment arms: (Total 1389 discrete episodes of DKA in 1255 pts)

Outcome measures

Primary: 2 GCS scores <14 during any hour during the first 24 hours of treatment

Secondary: short term memory (digit span), clinically apparent brain injury, short term/contextual memory and IQ 2-6 months after treatment

Results

• NO DIFFERENCE in primary or secondary outcomes between any of the treatment arms

Conclusion

• There is no apparent impact regarding type of fluid or rate of administration on neurologic deterioration in pediatric DKA patients
• Concerns regarding precipitating neurologic injury should not preclude administration of adequate intravenous fluids in the acute resuscitation of pediatric DKA patients

Caveats

• Study not powered to detect differences in rates of clinically apparent brain injury between groups (hence use of surrogate outcome measures like decline in GCS, impaired short term memory)
• Rates of administration in the "fast" group still slower than most adult patients receive (usually more in the range of 30-40 ml/kg of 0.9% NaCl over the first 2-4 hours)

Kupperman N, Ghetti S, Schunk J et al. Clinical Trial of Fluid Infusion Rates for Pediatric Diabetic Ketoacidosis NEJM 2018: 378(24); 2275-87.