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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 parameter

Plasma-Lyte-A (n = 34)

0.9% saline (n = 32)

P value

Risk ratio (95% CI)

Primary outcome

 Composite AKI

  AKI based on worst quartiles at 48 h, n (%)

13 (38.2)

15 (46.9)

0.491

1.42 (0.53, 3.86)

  AKI based on KDIGO and p-RIFLE at 48 h, n (%)

3 (8.8)

1 (3.1)

0.332

3.0 (0.29, 30.44)

 Individual outcomes of composite AKI

  Creatinine >75th percentile, n (%)

6 (17.6)

5 (15.6)

0.837

0.87 (0.22, 3.31)

  Urinary NGAL >75th percentile, n (%)

9 (27.3)

7 (21.9)

0.629

0.75 (0.23, 2.38)

  GFR < 25th percentile, n (%)

7 (20.6)

10 (31.2)

0.341

1.73 (0.56, 5.59)

Secondary outcomes

 Reduction in AKI at various time points

  0 h, n (%)

21 (61.8)

15 (46.9)

0.225

1.82 (0.69, 4.88)

  24 h, n (%)

4 (11.8)

3 (9.4)

0.753

1.28 (0.26, 6.27)

  48 h, n (%)

3 (8.8)

1 (3.1)

0.332

3.0 (0.29, 30.44)

 Time to resolution of AKI (hours)

22.1 (13.8, 30.5)

18.8 (15.1, 24.3)

0.494

0.98 (0.94, 1.03)

 Time to reach DKA endpoint (hours)

14.5 (12, 20)

16 (8, 20)

0.472

0.96 (0.86, 1.13)

 Chloride elevation first 4 h

3.5 (0.75, 7.25)

4.0 (1, 10)

0.403

 

 Chloride elevation first 8 h

4.0 (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)