Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery

NCT ID: NCT00250237

Last Updated: 2009-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-02-28

Brief Summary

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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

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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.

Conditions

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Post-Operative Delirium Hip Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Patients receiving blinded medication (Haloperidol or Placebo)

Group Type ACTIVE_COMPARATOR

Haloperidol

Intervention Type DRUG

Haloperidol 1mg twice daily during 72hours

B

Patients receiving blinded medication (Haloperidol or Placebo)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo 1mg twice daily during 72hours

Interventions

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Haloperidol

Haloperidol 1mg twice daily during 72hours

Intervention Type DRUG

placebo

Placebo 1mg twice daily during 72hours

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bronovo Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bronovo Hospital

Principal Investigators

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Boke Linso Sjirk Borger van der Burg, MD

Role: PRINCIPAL_INVESTIGATOR

Bronovo Hospital

Locations

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Bronovo Hospital

The Hague, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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05-56

Identifier Type: -

Identifier Source: org_study_id

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