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Table 3 Outcome measures between study groups

From: 0.9% saline versus Plasma-Lyte as initial fluid in children with diabetic ketoacidosis (SPinK trial): a double-blind randomized controlled trial

Outcome parameterPlasma-Lyte-A (n = 34)0.9% saline (n = 32)P valueRisk ratio (95% CI)
Primary outcome
 Composite AKI
  AKI based on worst quartiles at 48 h, n (%)13 (38.2)15 (46.9)0.4911.42 (0.53, 3.86)
  AKI based on KDIGO and p-RIFLE at 48 h, n (%)3 (8.8)1 (3.1)0.3323.0 (0.29, 30.44)
 Individual outcomes of composite AKI
  Creatinine >75th percentile, n (%)6 (17.6)5 (15.6)0.8370.87 (0.22, 3.31)
  Urinary NGAL >75th percentile, n (%)9 (27.3)7 (21.9)0.6290.75 (0.23, 2.38)
  GFR < 25th percentile, n (%)7 (20.6)10 (31.2)0.3411.73 (0.56, 5.59)
Secondary outcomes
 Reduction in AKI at various time points
  0 h, n (%)21 (61.8)15 (46.9)0.2251.82 (0.69, 4.88)
  24 h, n (%)4 (11.8)3 (9.4)0.7531.28 (0.26, 6.27)
  48 h, n (%)3 (8.8)1 (3.1)0.3323.0 (0.29, 30.44)
 Time to resolution of AKI (hours)22.1 (13.8, 30.5)18.8 (15.1, 24.3)0.4940.98 (0.94, 1.03)
 Time to reach DKA endpoint (hours)14.5 (12, 20)16 (8, 20)0.4720.96 (0.86, 1.13)
 Chloride elevation first 4 h3.5 (0.75, 7.25)4.0 (1, 10)0.403 
 Chloride elevation first 8 h4.0 (0.50, 8.50)6.0 (1, 9.5)0.608 
 Need for RRT, n (%)2 (5.9)0 (0)0.164 
 Need for ventilation, n (%)2 (5.9)1 (3.1)0.591 
 Mortality in hospital, n (%)2 (5.9)0(0)0.164 
 Length of ICU stay (hours)48 (48, 60)47 (24, 54)0.276 
 Length of Hospital stay (days)9 (8, 12)10.0 (8.25, 11)0.396 
 28-day survival, n (%)31 (94.1)31 (100)0.164 
  1. Data expressed as median (IQR)
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