Post-operative Haloperidol Versus Placebo for Prevention... | NCT00250237

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

NCT00250237

Sponsor

Bronovo Hospital

Status

Completed

Last Update Posted

Aug 7, 2009Estimated

Enrollment

220Actual

Phase

Phase 3

Conditions

Post-Operative Delirium
Hip Fracture

Interventions

Haloperidol
placebo

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Nov 2008Actual

Completion Date

Feb 2009Actual

First Submitted Date

Nov 7, 2005

First Submission Date that Met QC Criteria

Nov 7, 2005

First Posted Date

Nov 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2009

Last Update Posted Date

Aug 7, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Patients receiving blinded medication (Haloperidol or Placebo)	Drug: Haloperidol
B	Placebo Comparator	Patients receiving blinded medication (Haloperidol or Placebo)	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Haloperidol	Drug	Haloperidol 1mg twice daily during 72hours	A
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of post-operative delirium		72 hours post surgery

Secondary Outcomes

Measure	Description	Time Frame
Length of stay		days
Complications		during hospitalization

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boke Linso Sjirk Borger van der Burg, MD	Bronovo Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bronovo Hospital		The Hague	South Holland	2597 AX	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium
D006620	Hip Fractures

Ancestor Terms

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006220	Haloperidol

Ancestor Terms

ID	Term
D002090	Butyrophenones
D007659	Ketones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided