Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer
|ClinicalTrials.gov Identifier: NCT01539733|
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Delirium Advanced Cancer||Drug: Olanzapine Drug: Haloperidol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
After randomisation to olanzapine treatment, olanzapine will be started at an initial dose of 2,5 - 5 mg orally or intramuscularly, after 2 hours subsequent titration of dosage will be based on clinical judgement with a maximum of 20 mg per 24 hours divided over a maximum of 3 gifts. Sustenance dose will consist of half of the total titrated dose per 24 hours in one gift.
Other Name: Zyprexa
|Active Comparator: Haloperidol||
After randomisation to haloperidol treatment, haloperidol dosing will be titrated, with repeated dosing of 0,5 - 2mg orally or subcutaneously every 40 minutes until signs of delirium diminish, with a maximum of 20 mg orally or 10 mg subcutaneously per 24 hours. Sustenance dose will consist of half of the total titrated dose per 24 hours in one or two gifts.
Other Name: Haldol
- DRS-R-98 severity rating score [ Time Frame: Until clearance of the delirium signs or for a maximum of 2 weeks ]Primary endpoint for this trial is a DRS-R-98 severity rating score <15,25, as this is a measure for establishing clearance of delirium.
- Delirium resolution rate [ Time Frame: Until clearance of the delirium signs or for a maximum of 2 weeks ]Secondary endpoint is the amount of time elapsed between start of treatment and diminishing of the signs of delirium (DOS <3, DSR-R-98 <15,25).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539733
|VU University Medical Center|
|Amsterdam, Netherlands, 1081HV|
|Principal Investigator:||Henk MW Verheul, MD, PhD||VU University Medical Center|