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Table 1 Baseline characteristics of the intention-to-treat population

From: Loxapine to control agitation during weaning from mechanical ventilation

 

Loxapine (n = 48)

Placebo (n = 39)

p Value

Age, years (SD)

59.6 (15.6)

51 (17.7)

0.02

Male sex, n (%)

35 (74.5)

31 (79.5)

0.6

SAPS II score (SD)

48.2 (17.2)

53.7 (17.9)

0.15

SOFA score [IQR]

9 [5–12]

9 [7–11]

0.8

Alcohol consumption, n (%)

13 (28)

17 (44)

0.12

Toxic drug abuse, n (%)

5 (11)

6 (15)

0.54

Psychoactive drug use, n (%)

8 (17)

10 (26)

0.33

Indication for MV

 Acute respiratory failure, n (%)

23 (49)

16 (41)

0.46

 Shock, n (%)

12 (25)

9 (23)

0.48

 Coma, n (%)

8 (17)

9 (23)

0.48

Co-morbid conditions

 COPD, n (%)

5 (11)

4 (10)

1.0

 Congestive heart disease, n (%)

6 (13)

4 (10)

1.0

 Chronic renal failure, n (%)

2 (4)

0 (0)

0.5

 Hepatic disease, n (%)

1 (2)

1 (3)

1.0

Duration of MV before randomisation, days [IQR]

5 [3–7]

6 [5–8]

0.06

Cumulative amount of sedative drugs in the previous 24 h

 Midazolam, mg

114 [40–230]

120 [57–341]

0.5

 Fentanyl, μg

2150 [1731–4000]

2700 [2550–4300]

0.6

 Sufentanil, μg

247.5 [107–333.75]

270 [130–638.75]

0.2

 Propofol, mg

1440 [750–2550]

1520 [1085–2400]

0.3

  1. Abbreviations: COPD Chronic obstructive pulmonary disease, MV Mechanical ventilation, SAPS II Simplified Acute Physiology Score II (calculated in the first 24 h of admission in ICU), SOFA Sepsis-related Organ Failure assessment (calculated at randomisation)
  2. Data are n (%), median (IQR) or mean (SD)