NCT00250237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

3 years

First QC Date

November 7, 2005

Last Update Submit

August 6, 2009

Conditions

Post-Operative DeliriumHip Fracture

Keywords

Post-operative deliriumhip fracture

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-operative delirium

    72 hours post surgery

Secondary Outcomes (2)

  • Length of stay

    days

  • Complications

    during hospitalization

Study Arms (2)

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

HaloperidolDRUG

Haloperidol 1mg twice daily during 72hours

A
placeboDRUG

Placebo 1mg twice daily during 72hours

B

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Hip fracture
  • years and older

You may not qualify if:

  • Contra-indications for the use of haloperidol
  • Pre-operative delirium
  • Pre-operative use of haloperidol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bronovo Hospital

The Hague, South Holland, 2597 AX, Netherlands

Location

MeSH Terms

Conditions

Emergence DeliriumHip Fractures

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic Chemicals

Study Officials

  • Boke Linso Sjirk Borger van der Burg, MD

    Bronovo Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2005

First Posted

November 8, 2005

Study Start

November 1, 2005

Primary Completion

November 1, 2008

Study Completion

February 1, 2009

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

NL(1)