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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00286936
Recruitment Status : Terminated (Slow inclusion resulting in premature termination due to logistics)
First Posted : February 6, 2006
Last Update Posted : August 30, 2011
Sponsor:
Collaborator:
IMK Fonden
Information provided by:
Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE February 3, 2006
First Posted Date  ICMJE February 6, 2006
Last Update Posted Date August 30, 2011
Study Start Date  ICMJE February 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2006)
Incidence and severity of postoperative delirium
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2006)
  • Sleep quality
  • mobilization
  • loss of functional ability
  • length of stay
  • sedation
  • nocturnal nursing events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo
Official Title  ICMJE Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Hip Fracture
  • Delirium
Intervention  ICMJE Drug: Zolpidem
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: February 3, 2006)
96
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00286936
Other Study ID Numbers  ICMJE HHSG-RCT-05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE IMK Fonden
Investigators  ICMJE
Study Director: Nicolai B Foss, MD Hvidovre University Hospital
PRS Account Hvidovre University Hospital
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP