Contact information
Type
Scientific
Primary contact
Mr Boke Linse Sjirk Borger van der Burg
ORCID ID
Contact details
Bronovolaan 4
The Hague
2597 AX
Netherlands
+31 (0)703124141
boudewijn.borgervanderburg@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00250237
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
In this study we want to determine if treatment with haloperidol directly after acute hip surgery in high risk patients protects against developing a post-operative delirium.
Ethics approval
Yes, Medical Ethics Committee Southwest Holland (Medisch Ethische Toetsingscommissie [METC] Zuidwest Holland). Date of approval: September 2nd 2005.
METC number: 05-56.
Study design
Randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Hip fracture
Intervention
Post-operative Haloperidol versus Placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Haloperidol
Primary outcome measures
Incidence of post-operative delirium
Secondary outcome measures
1. Mortality
2. Activities of daily living (ADL) dependency
Overall trial start date
10/11/2005
Overall trial end date
10/11/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients aged 75 years and older
2. Hip Fracture
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
206
Participant exclusion criteria
1. Younger patients
2. Pre-operative delirium
3. Contra-indications for use of haloperidol
Recruitment start date
10/11/2005
Recruitment end date
10/11/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Bronovolaan 4
The Hague
2597 AX
Netherlands
Sponsor information
Organisation
Research Fund Bronovo Hospital (The Netherlands)
Sponsor details
Bronovolaan 5
The Hague
2597 AX
Netherlands
+31 (0)703124141
sgieskes@bronovo.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Research Fund Bronovo Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary