Hip FracturePhase 4NCT00286936
Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo
A Phase 4 study testing Zolpidem in people with Hip Fracture and Delirium, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hip Fracture, Delirium
- What is being tested?
- Zolpidem
- How many people
- 96 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2004to Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Primary hip fracture, no substance abuse, no regular opioid, corticosteroid or benzodiazepine therapy, hepatic insufficiency, myastenia gravis, allergies to drug components
Who cannot join
- Severe respiratory insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
To examine the influence of regular hypnotic therapy on the incidence of delirium after hip fracture surgery
Read the 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.
- Conditions
- Hip Fracture, Delirium
- Being tested
- Zolpidem
- Keywords
- Hip fracture, delirium, sleep disturbance, hypnotic
- Medical subject headings
- Hip Fractures, Delirium, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolpidemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of postoperative delirium
Secondary outcomes (6)
Sleep quality
mobilization
loss of functional ability
length of stay
sedation
nocturnal nursing events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startFeb 2004
- Study completionJan 2007
Why it stopped: Slow inclusion resulting in premature termination due to logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- IMK Fonden
- Investigators
- Nicolai B Foss, MD, Study director, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286936
- Sponsor's protocol ID
- HHSG-RCT-05
- Status last verified
- Sep 2006
- First submitted
- 3 Feb 2006
- Last updated
- 30 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Delirium in Hip Fracture Patients Randomized to Regular Hypnotics vs Placebo
- ClinicalTrials.gov ID
- NCT00286936
- Acronym / sponsor ID
- HHSG-RCT-05
- Conditions
- Hip Fracture, Delirium
- Keywords
- Hip fracture, delirium, sleep disturbance, hypnotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow inclusion resulting in premature termination due to logistics
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- IMK Fonden
- Study start
- Feb 2004
- Study completion
- Jan 2007 (actual)
- First posted
- 6 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Primary hip fracture, no substance abuse, no regular opioid, corticosteroid or benzodiazepine therapy, hepatic insufficiency, myastenia gravis, allergies to drug components
Key exclusion criteria (1 listed)
- Severe respiratory insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zolpidem | Drug | – |
Primary outcome
Incidence and severity of postoperative delirium
6 secondary outcomes
Sleep quality
mobilization
loss of functional ability
length of stay
sedation
nocturnal nursing events
Results and safety
The study was stopped early (reason given: Slow inclusion resulting in premature termination due to logistics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolai B Foss, MD study director
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zolpidem in people with Hip Fracture and Delirium, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow inclusion resulting in premature termination due to logistics). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of postoperative delirium. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2011.