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Clinical Trial: Post-Operative Haloperidol Versus Placebo for Prevention of Post-Operative Delirium After Acute Hip Surgery.
This study is not yet open for patient recruitment.
Verified by Bronovo Hospital September 2005
|
Purpose
In this study we want to determine if treatment with haloperidol direct post-operatively after acute hip surgery in high risk patients protects against developing a post-operative delirium.
| Condition | Intervention | Phase |
|---|---|---|
| Post-Operative Delirium Hip Fracture | Drug: Haloperidol versus Placebo | Phase III |
MedlinePlus related topics: Hip Injuries and Disorders
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title: Randomised Double-Blind Placebo-Controlled Study of Post-Operative Haloperidol Versus Placebo for Prevention of Post-Operative Delirium After Acute Hip Surgery.
Further study details as provided by Bronovo Hospital:
Primary Outcomes: Incidence of post-operative delirium
Secondary Outcomes: Length of stay.; Mortality.; ADL dependence at 3 months.
Expected Total Enrollment: 206
Secondary Outcomes: Length of stay.; Mortality.; ADL dependence at 3 months.
Expected Total Enrollment: 206
Study start: November 2005; Expected completion: February 2008
Last follow-up: January 2008; Data entry closure: January 2008
A post-operative delirium is a serious and frequent (35-65%) complication with high morbidity and mortality in high risk patients. In this study we investigate wether we can prevent a delirium from occuring after surgery in patients with a hip fracture of 75years of age and older. It''''s a randomised double-blind single centre placebo-controlled study of haloperidol versus placebo.
Eligibility
Ages Eligible for Study: 75 Years and above, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- hip fracture
- 75years and older
Exclusion Criteria:
- younger patients
- contra-indications for the use of haloperidol
- pre-operative delirium
- pre-operative use of haloperidol
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00250237
Boke Linso Sjirk Borger van der Burg, MD +31703124141 Ext. 5659 boudewijn.borgervanderburg@gmail.com
Simone van Klink +31703124141 Ext. 5579 spmvanklink@hotmail.com
Simone van Klink +31703124141 Ext. 5579 spmvanklink@hotmail.com
Netherlands, Zuid Holland
Bronovo Hospital, The Hague, Zuid Holland, 2597 AX, Netherlands
Boke Linso Sjirk Borger van der Burg, MD, Principal Investigator
Study chairs or principal investigators
Boke Linso Sjirk Borger van der Burg, MD, Principal Investigator, Bronovo Hospital
More Information
Study ID Numbers: 05-56
Last Updated: December 8, 2005
Record first received: November 7, 2005
ClinicalTrials.gov Identifier: NCT00250237
Health Authority: The Netherlands: Inspection for Public Health
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: November 7, 2005
ClinicalTrials.gov Identifier: NCT00250237
Health Authority: The Netherlands: Inspection for Public Health
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Haldol Tablets (Drug Digest)
- Haloperidol Tablets (Drug Digest)
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