1,800
Participants
Start Date
June 30, 2013
Primary Completion Date
December 31, 2016
Study Completion Date
March 31, 2017
Haloperidol 1 mg/q8h
"Patients receive prophylactic haloperidol until discharge from the ICU or when delirium occurs. In the latter case study drug will be stopped and patients will be subsequently treated according to the delirium protocol with open-label haloperidol. To avoid unnecessary risk for side-effects the dose will be halved in patients:~* aged ≥ 80 years~* weight ≤ 50 kg~* liver failure~Patients with an adjusted dosage of study drug remain allocated to their original group.~In case of occurrence of QTc-time prolongation the study drug will be stopped. After normalisation of QTc-time (\<500msec.) the study drug will be restarted. If QTc-time becomes prolonged again, the study drug will be stopped definitively. The patient will remain allocated to the original study group."
Haloperidol 2 mg/q8h
"Patients receive prophylactic haloperidol until discharge from the ICU or when delirium occurs. In the latter case study drug will be stopped and patients will be subsequently treated according to the delirium protocol with open-label haloperidol. To avoid unnecessary risk for side-effects the dose will be halved in patients:~* aged ≥ 80 years~* weight ≤ 50 kg~* liver failure~Patients with an adjusted dosage of study drug remain allocated to their original group.~In case of occurrence of QTc-time prolongation the study drug will be stopped. After normalisation of QTc-time (\<500msec.) the study drug will be restarted. If QTc-time becomes prolonged again, the study drug will be stopped definitively. The patient will remain allocated to the original study group."
Placebo
Sodium Chloride 0.9%
Radboud University Medical Centre, Nijmegen
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Radboud University Medical Center
OTHER