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Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo

Primary Purpose

Hip Fracture, Delirium

Status

Terminated

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Zolpidem

About this trial

This is an interventional prevention trial for Hip Fracture focused on measuring Hip fracture, delirium, sleep disturbance, hypnotic

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Primary hip fracture, no substance abuse, no regular opioid, corticosteroid or benzodiazepine therapy, hepatic insufficiency, myastenia gravis, allergies to drug components Exclusion Criteria: Severe respiratory insufficiency

Sites / Locations

Hvidovre University Hospital

Outcomes

Primary Outcome Measures

Incidence and severity of postoperative delirium

Secondary Outcome Measures

Sleep quality

mobilization

loss of functional ability

length of stay

sedation

nocturnal nursing events

Full Information

NCT ID

NCT00286936

First Posted

February 3, 2006

Last Updated

August 29, 2011

Sponsor

Hvidovre University Hospital

Collaborators

IMK Fonden

1. Study Identification

Unique Protocol Identification Number

NCT00286936

Brief Title

Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo

Official Title

Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Terminated

Why Stopped

Slow inclusion resulting in premature termination due to logistics

Study Start Date

February 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hvidovre University Hospital

Collaborators

IMK Fonden

4. Oversight

5. Study Description

Brief Summary

To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery

Detailed Description

Delirium is prevalent after hip fracture surgery. Delirium has been linked to postoperative sleep disturbances. Zolpidem is a non-benzodiazepine hypnotic that preserves REM sleep. The present study investigates the incidence of delirium in hip fracture patients randomized to Zolpidem treatment 5 mg vs placebo in the perioperative phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Fracture, Delirium

Keywords

Hip fracture, delirium, sleep disturbance, hypnotic

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Zolpidem

Primary Outcome Measure Information:

Title

Incidence and severity of postoperative delirium

Secondary Outcome Measure Information:

Title

Sleep quality

Title

mobilization

Title

loss of functional ability

Title

length of stay

Title

sedation

Title

nocturnal nursing events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolai B Foss, MD

Organizational Affiliation

Hvidovre University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Hvidovre University Hospital

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

12. IPD Sharing Statement

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Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo

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