Back to resultsPost-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery
Primary Purpose
Post-Operative Delirium, Hip Fracture
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Haloperidol
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Post-Operative Delirium focused on measuring Post-operative delirium, hip fracture
Eligibility Criteria
Inclusion Criteria: Hip fracture 75 years and older Exclusion Criteria: Contra-indications for the use of haloperidol Pre-operative delirium Pre-operative use of haloperidol
Sites / Locations
- Bronovo Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A
B
Arm Description
Patients receiving blinded medication (Haloperidol or Placebo)
Patients receiving blinded medication (Haloperidol or Placebo)
Outcomes
Primary Outcome Measures
Incidence of post-operative delirium
Secondary Outcome Measures
Length of stay
Complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00250237
Brief Title
Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery
Official Title
Randomised Double-blind Placebo-controlled Study of Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bronovo Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study the investigators 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.
Detailed Description
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 whether we can prevent a delirium from occuring after surgery in patients with a hip fracture of 75 years of age and older. It's a randomised double-blind single centre placebo-controlled study of haloperidol versus placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Delirium, Hip Fracture
Keywords
Post-operative delirium, hip fracture
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Patients receiving blinded medication (Haloperidol or Placebo)
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Patients receiving blinded medication (Haloperidol or Placebo)
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Intervention Description
Haloperidol 1mg twice daily during 72hours
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo 1mg twice daily during 72hours
Primary Outcome Measure Information:
Title
Incidence of post-operative delirium
Time Frame
72 hours post surgery
Secondary Outcome Measure Information:
Title
Length of stay
Time Frame
days
Title
Complications
Time Frame
during hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Hip fracture
75 years and older
Exclusion Criteria:
Contra-indications for the use of haloperidol
Pre-operative delirium
Pre-operative use of haloperidol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boke Linso Sjirk Borger van der Burg, MD
Organizational Affiliation
Bronovo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronovo Hospital
City
The Hague
State/Province
Zuid Holland
ZIP/Postal Code
2597 AX
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery
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