Table 4

Results: safety

Dexmedetomidine

Haloperidol

P

ICU mortality, n

0

0

1.00

Hospital mortality, n

0

1

0.31

QTc interval prior to study drug, sec: mean (95% CI)

0.411 (0.384 to 0.438)

0.426 (0.395 to 0.457)

0.41

QTc interval while on study drug, sec: mean (95% CI)

0.395 (0.365 to 0.425)

0.446 (0.423 to 0.457)

0.0061

Patients with abnormal QTc interval (> 0.440 sec) while on study drug: %

40

40

1.00

Patients with longer QTc interval than baseline while on study drug: %

30

70

0.07

Arrhythmia while on study drug: %

20

20

1.00

Patients requiring norepinephrine* infusion while on study drug: %

80

50

0.16

Patients newly requiring norepinephrine or a 20% increase in norepinephrine* infusion in the 8 hours after commencement of study drug: %

20

20

1.00

Of patients requiring norepinephrine, proportion of the time while on study drug receiving norepinephrine: mean (95%CI)

59.8 (17.9 to 100.0)

34.4 (0.0 to 87.1)

0.37

Of patients requiring norepinephrine, level of infusion (μg/min) while on study drug: mean (95%CI)

2.51 (0.07 to 4.90)

3.97 (0.00 to 11.07)

0.55

Any adverse event attributed to the study drug: %

0

10**

0.31

Patients requiring reintubation: n, %

0

0

1.00

* norepinephrine was the only inotropic or vasopressor medication used in any study patient

** excessive prolongation of the QTc interval, necessitating drug discontinuation

CI = confidence interval; ICU = intensive care unit; QTc = QT interval corrected for heart rate.

Reade et al. Critical Care 2009 13:R75   doi:10.1186/cc7890