Post-operative Haloperidol versus Placebo for prevention of post-operative delirium after acute hip surgery
| ISRCTN | ISRCTN73128419 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73128419 |
| ClinicalTrials.gov number | NCT00250237 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/11/2005
- Registration date
- 03/02/2006
- Last edited
- 01/02/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Boke Linse Sjirk Borger van der Burg
Scientific
Scientific
Bronovolaan 4
The Hague
2597 AX
Netherlands
| Phone | +31 (0)703124141 |
|---|---|
| boudewijn.borgervanderburg@gmail.com |
Study information
| Study design | Randomised double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Post-operative Haloperidol versus Placebo for prevention of post-operative delirium after acute hip surgery |
| Study objectives | 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(s) | Yes, Medical Ethics Committee Southwest Holland (Medisch Ethische Toetsingscommissie [METC] Zuidwest Holland). Date of approval: September 2nd 2005. METC number: 05-56. |
| Health condition(s) or problem(s) studied | Hip fracture |
| Intervention | Post-operative Haloperidol versus Placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Haloperidol |
| Primary outcome measure | Incidence of post-operative delirium |
| Secondary outcome measures | 1. Mortality 2. Activities of daily living (ADL) dependency |
| Overall study start date | 10/11/2005 |
| Completion date | 10/11/2007 |
| Reason abandoned (if study stopped) | Lost randomisation key |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 206 |
| Key inclusion criteria | 1. Patients aged 75 years and older 2. Hip Fracture |
| Key exclusion criteria | 1. Younger patients 2. Pre-operative delirium 3. Contra-indications for use of haloperidol |
| Date of first enrolment | 10/11/2005 |
| Date of final enrolment | 10/11/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Bronovolaan 4
The Hague
2597 AX
Netherlands
2597 AX
Netherlands
Sponsor information
Research Fund Bronovo Hospital (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Bronovolaan 5
The Hague
2597 AX
Netherlands
| Phone | +31 (0)703124141 |
|---|---|
| sgieskes@bronovo.nl | |
"ROR" |
https://ror.org/03r781319 |
Funders
Funder type
Hospital/treatment centre
Research Fund Bronovo Hospital
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration 2015 short research article in https://doi.org/10.9734/BJMMR/2015/17815 (added 01/02/2019) |
| IPD sharing plan |
Editorial Notes
01/02/2019: Short research article reference added
31/01/2019: No publications found, verifying results status with the principal investigator
