pRophylactic halopEriDol Use for Delirium in iCu patiEnts With a High Risk for Delirium

PHASE4CompletedINTERVENTIONAL
Enrollment

1,800

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

December 31, 2016

Study Completion Date

March 31, 2017

Conditions
Delirium
Interventions
DRUG

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."

DRUG

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."

DRUG

Placebo

Sodium Chloride 0.9%

Trial Locations (1)

6500HB

Radboud University Medical Centre, Nijmegen

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

lead

Radboud University Medical Center

OTHER

NCT01785290 - pRophylactic halopEriDol Use for Delirium in iCu patiEnts With a High Risk for Delirium | Biotech Hunter | Biotech Hunter