DeliriumPhase 4NCT02413554
Rivastigmine Patch Effect on the Post-operative Delirium in Patients at Risk of Dementia.
A Phase 4 study testing Rivastigmine patch in people with Delirium, run by Chung-Ang University Hospital.
Trial summary
Delirium is a common and serious condition and is associated with adverse outcome. The elderly who have cognitive dysfunction are expected to show delirium more frequently. It is most likely that delirium represents a response to impaired cholinergic neurotransmission. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Rivastigmine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 2015
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Consecutively enrolled the patients who is going to operation after femur neck fracture.
- Patients agree to the informed consent.
Who cannot join
- depressive mood and their geriatric depression scale is over 6 / 15.
- Their Korean version MMSE(minimental status examination) are over 25, or global dementia scale (GDS) are under 3 or over 5.
- any delirious state at pre-operation period by DSM IV and CAM (Confusion Assessment Method)
About this study
Official title: Rivastigmine Patch Effect on the Post-operative Delirium Limited to Femur Neck Fracture Operation in Patients at Risk of Dementia.
Delirium is a common and serious condition and is associated with adverse outcome. The elderly who have cognitive dysfunction are expected to show delirium more frequently. It is most likely that delirium represents a response to impaired cholinergic neurotransmission. Investigators aimed to establish the preventive effect of the cholinesterase inhibitor, rivastigmine patch, on the post-operative delirium limited to femur neck fracture operation in patients at risk of dementia.
Read the detailed description
Investigators evaluated the delirium prevention effect of rivastigmine patch in patients with femur neck fracture and cognitive impairment. Investigators measured the frequency and severity of post-operation delirium in the patch applied and non-applied subjects.
- Conditions
- Delirium
- Being tested
- Rivastigmine patch
- Keywords
- acetylcholinesterase inhibitors, rivastigmine patch, post-operational delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivastigmine patchDrug
Also called exelon patch
acetylcholine esterase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Patch applied patients | Experimental | The investigators had enrolled consecutively the patients who were going to operation after femur neck fracture.
Participants were applied the 5 unit rivastigmine patches from 3 days before and 7 days after the femur neck operation. Receives: Drug: Rivastigmine patch |
| Patch non-applied patients | No intervention | The participants who were going to operation after femur neck fracture were not applied the rivastigmine patches. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of participants with delirium
investigators evaluated the delirium frequency in rivastigmine applied participants comparing with non-applied participants.
Measured: up to 7th days
Secondary outcomes (1)
delirium severity using delirium rating scale
to compare the severity of delirium in rivastigmine patch applied participants with non-applied
Measured: up to 7th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startApr 2013
- Primary completionMar 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Young Chul, Chung-Ang University Hospital
- Investigators
- Young Chul Youn, MD, PhD, Principal investigator, Dept of Neurology, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413554
- Sponsor's protocol ID
- NR0001
- Status last verified
- Apr 2015
- First submitted
- 2 Apr 2015
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivastigmine Patch Effect on the Post-operative Delirium Limited to Femur Neck Fracture Operation in Patients at Risk of Dementia.
- ClinicalTrials.gov ID
- NCT02413554
- Acronym / sponsor ID
- NR0001
- Conditions
- Delirium
- Keywords
- acetylcholinesterase inhibitors, rivastigmine patch, post-operational delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Apr 2015 (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.
Delirium is a common and serious condition and is associated with adverse outcome. The elderly who have cognitive dysfunction are expected to show delirium more frequently. It is most likely that delirium represents a response to impaired cholinergic neurotransmission. Investigators aimed to establish the preventive effect of the cholinesterase inhibitor, rivastigmine patch, on the post-operative delirium limited to femur neck fracture operation in patients at risk of dementia.
Detailed description
Investigators evaluated the delirium prevention effect of rivastigmine patch in patients with femur neck fracture and cognitive impairment. Investigators measured the frequency and severity of post-operation delirium in the patch applied and non-applied subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patch applied patients | Experimental | Drug: Rivastigmine patchThe investigators had enrolled consecutively the patients who were going to operation after femur neck fracture. Participants were applied the 5 unit rivastigmine patches from 3 days before and 7 days after the femur neck operation. |
| Patch non-applied patients | No intervention | –The participants who were going to operation after femur neck fracture were not applied the rivastigmine patches. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Consecutively enrolled the patients who is going to operation after femur neck fracture.
- Patients agree to the informed consent.
Key exclusion criteria (3 listed)
- depressive mood and their geriatric depression scale is over 6 / 15.
- Their Korean version MMSE(minimental status examination) are over 25, or global dementia scale (GDS) are under 3 or over 5.
- any delirious state at pre-operation period by DSM IV and CAM (Confusion Assessment Method)
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 |
|---|---|---|
| Rivastigmine patchAlso: exelon patchacetylcholine esterase inhibitor | Drug | Patch applied patients |
Primary outcome
the number of participants with delirium
Time frame: up to 7th days
investigators evaluated the delirium frequency in rivastigmine applied participants comparing with non-applied participants.
1 secondary outcome
delirium severity using delirium rating scale
Time frame: up to 7th days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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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.
Young Chul Youn, MD, PhD principal investigator
Dept of Neurology, Chung-Ang University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivastigmine patch in people with Delirium, run by Chung-Ang University Hospital.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the number of participants with delirium (time frame: up to 7th days). 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 10 Apr 2015.