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Table 4 Safety dosing group analysis

From: Right dose, right now: bedside, real-time, data-driven, and personalised antibiotic dosing in critically ill patients with sepsis or septic shock—a two-centre randomised clinical trial

 

AutoKinetics high dosing group

(36)

AutoKinetics low dosing group

(24)

AutoKinetics

Normal dosing group

(72)

Control

(120)

p value (adjusted)a

ICU mortality, n (%)

11 (30.6)

7 (29.2)

27 (37.5)

44 (36.7)

0.801 (0.998)

Hospital mortality, n (%)

11 (30.6)

9 (37.5)

27 (37.5)

47 (39.2)

0.667 (0.997)

28-day mortality, n (%)

11 (30.6)

7 (29.2)

27 (37.5)

48 (40.0)

06.27 (0.997)

6-month mortality, n (%)

13 (36.1)

10 (41.7)

33 (45.8)

59 (49.2)

0.557 (0.997)

New onset AKI, n (%)

16 (44.4)

3 (12.5)

25 (34.7)

50 (41.7)

0.041 (0.416)

Highest KDIGO stage, n (%)

    

0.119 (0.752)

 0

10 (27.8)

5 (20.8)

15 (20.8)

15 (12.5)

 

 1

4 (11.1)

3 (5.6)

4 (5.6)

19 (15.8)

 

 2

16 (44.4)

6 (25.0)

25 (34.7)

44 (36.7)

 

 3

6 (16.7)

10 (41.7)

28 (38.9)

42 (35.0)

 

Received CVVH, n (%)

2 (5.6)

5 (20.8)

11 (15.3)

19 (15.8)

0.352 (0.980)

Days free from CVVH, median (IQR)

3.0 (2.0 to 9.2)

3.0 (1.0 to 10.5)

4.5 (2.0 to 10.0)

4.0 (2.0 to 10.0)

0.795 (0.998)

SOFA score at 96 h, median (IQR)

9.0 (5.0 to 12.2)

13.5 (10.0 to 24.0)

9.0 (5.8 to 14.2)

10.0 (5.9 to 19.2)

0.075 (0.607)

Delta SOFA score at 96 h, median (IQR)

− 1.0 (− 3.0 to 4.0)

0.0 (− 1.5 to 4.0)

0.0 (− 3.0 to 3.2)

0.0 (− 2.0 to 4.0)

0.523 (0.997)

Hospital LOS, median (IQR)

12.7 (5.4 to 26.5)

29.3 (1.1 to 37.4)

14.0 (6.5 to 29.3)

12.2 (3.4 to 28.4)

0.828 (0.998)

ICU LOS, median (IQR)

2.3 (1.8 to 7.0)

3.5 (1.1 to 11.2)

4.2 (1.6 to 11.7)

3.6 (1.0 to 11.0)

0.792 (0.998)

Coadministered study antibiotic, n (%)

     

 Vancomycin

6 (17.6)

4 (15.4)

19 (26.4)

26 (21.7)

 

 Ciprofloxacin

4 (11.8)

10 (38.5)

19 (26.4)

38 (31.7)

 

 Meropenem

2 (5.9)

2 (7.7)

9 (12.5)

5 (4.2)

 

 Ceftriaxone

12 (35.3)

2 (7.7)

17 (23.6)

28 (23.3)

 
  1. Safety groups (< 50% & > 200% of normal, unadjusted for kidney function, daily dose) are based on the cumulative dose in the first 24 h after randomisation for the primary antibiotic
  2. AKI, Acute Kidney Injury; CVVH, Continuous Veno-Venous Hemofiltration; KDIGO, Kidney Disease: Improving Global Outcomes; LOS, Length of stay; SOFA, Sequential Organ Failure Assessment; IQR, interquartile range
  3. ap value was adjusted for multiplicity using the Holm-Sidak method