DeliriumPhase 3NCT00257868
Rivastigmine for the Prevention of Postoperative Delirium in Patients Undergoing Cardiac Surgery
A Phase 3 study testing Rivastigmine prevention of delirium in people with Delirium, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether Rivastigmine is effective for the prevention of postoperative delirium in patients undergoing cardiac surgery. 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 prevention of delirium
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2006to Jul 2007
- Phase
- Phase 3
- 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
- Patients undergoing cardiac surgery with use of extracorporeal circulation
- Aged 65 or more
Who cannot join
- "redo" procedures
- anticipated use of succinylcholine during operation
- contraindications to rivastigmine
- preoperative mini mental score < 15
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rivastigmine for the Prevention of Postoperative Delirium After Cardiac Surgery
The purpose of this study is to determine whether Rivastigmine is effective for the prevention of postoperative delirium in patients undergoing cardiac surgery.
Read the detailed description
Postoperative delirium is a frequent complication after cardiac surgery. In the literature an incidence ranging from 0 - 72 % is reported. The aetiology of this complication is multifactorial. A decline in cerebral cholinergic transmission as well as perioperative cerebral hypoperfusion or a systemic inflammatory response triggered by the extracorporeal circulation have been suspected. Advanced age is the most important patient-related risk factor. A perioperative delirium is an extremely unpleasant experience for the affected patients. Equally important is the fact that a delirium is associated with a prolonged length of stay on the intensive care unit and in hospital. Furthermore, patients who develop delirium have an increased six-month mortality. Recently successful treatment and prevention of the delirium with cholinesterase inhibitors such as rivastigmine have been reported.
The proposed study will test the hypothesis that prophylactically administered rivastigmine is able to prevent or at least reduce the symptoms of the postoperative delirium in elderly patients undergoing elective cardiac surgery with extracorporeal circulation.
This study is designed as a double blind randomised placebo controlled trial. Half the patients will receive placebo. The other half will receive rivastigmine 1.5m-1.5mg-1.5mg (oral solution), starting on the evening preceding the operation and for the first seven days postoperatively. Patients in both groups who develop delirium will be treated with a rescue medication consisting of lorazepam and haloperidol.
Measurements will include the incidence of delirium assessed using the Confusion Assessment Method (CAM). The severity of symptoms will by characterised by the Mini Mental Score and clock drawing. Further measurements will include the prescribed doses of rescue medication, the length of stay on intensive care and in hospital, the time of extracorporeal circulation, and laboratory parameters such as CRP, albumin, lymphocyte count, vitamin B12 and folic acid levels. Side effects of rivastigmine will be quantified.
The primary endpoint of this study is the incidence of delirium. Secondary endpoints will be the severity of delirium, the used doses of rescue medication, and length of stay (intensive care and hospital).
- Conditions
- Delirium
- Being tested
- Rivastigmine prevention of 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 prevention of deliriumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of postoperative delirium within 7 days after cardiac surgery
Secondary outcomes (3)
Severity of delirium occurring within 7 days after cardiac surgery
Length of stay (intensive care and hospital)
Amount of drugs used for rescue therapy of delirium
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startJan 2006
- Study completionJul 2007
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.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Luzius A Steiner, MD PhD, Principal investigator, Department of Anaesthesia, University Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257868
- Sponsor's protocol ID
- EKBB 204/05
- Other IDs
- CENA713CCH01
- Status last verified
- Jul 2007
- First submitted
- 22 Nov 2005
- Last updated
- 31 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivastigmine for the Prevention of Postoperative Delirium After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00257868
- Acronym / sponsor ID
- EKBB 204/05
- Conditions
- Delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jan 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 23 Nov 2005 (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.
The purpose of this study is to determine whether Rivastigmine is effective for the prevention of postoperative delirium in patients undergoing cardiac surgery.
Detailed description
Postoperative delirium is a frequent complication after cardiac surgery. In the literature an incidence ranging from 0 - 72 % is reported. The aetiology of this complication is multifactorial. A decline in cerebral cholinergic transmission as well as perioperative cerebral hypoperfusion or a systemic inflammatory response triggered by the extracorporeal circulation have been suspected. Advanced age is the most important patient-related risk factor. A perioperative delirium is an extremely unpleasant experience for the affected patients. Equally important is the fact that a delirium is associated with a prolonged length of stay on the intensive care unit and in hospital. Furthermore, patients who develop delirium have an increased six-month mortality. Recently successful treatment and prevention of the delirium with cholinesterase inhibitors such as rivastigmine have been reported.
The proposed study will test the hypothesis that prophylactically administered rivastigmine is able to prevent or at least reduce the symptoms of the postoperative delirium in elderly patients undergoing elective cardiac surgery with extracorporeal circulation.
This study is designed as a double blind randomised placebo controlled trial. Half the patients will receive placebo. The other half will receive rivastigmine 1.5m-1.5mg-1.5mg (oral solution), starting on the evening preceding the operation and for the first seven days postoperatively. Patients in both groups who develop delirium will be treated with a rescue medication consisting of lorazepam and haloperidol.
Measurements will include the incidence of delirium assessed using the Confusion Assessment Method (CAM). The severity of symptoms will by characterised by the Mini Mental Score and clock drawing. Further measurements will include the prescribed doses of rescue medication, the length of stay on intensive care and in hospital, the time of extracorporeal circulation, and laboratory parameters such as CRP, albumin, lymphocyte count, vitamin B12 and folic acid levels. Side effects of rivastigmine will be quantified.
The primary endpoint of this study is the incidence of delirium. Secondary endpoints will be the severity of delirium, the used doses of rescue medication, and length of stay (intensive care and hospital).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients undergoing cardiac surgery with use of extracorporeal circulation
- Aged 65 or more
Key exclusion criteria (4 listed)
- "redo" procedures
- anticipated use of succinylcholine during operation
- contraindications to rivastigmine
- preoperative mini mental score < 15
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 prevention of delirium | Drug | – |
Primary outcome
Development of postoperative delirium within 7 days after cardiac surgery
3 secondary outcomes
Severity of delirium occurring within 7 days after cardiac surgery
Length of stay (intensive care and hospital)
Amount of drugs used for rescue therapy of delirium
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 31 Jul 2007.
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Luzius A Steiner, MD PhD principal investigator
Department of Anaesthesia, University Hospital Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivastigmine prevention of delirium in people with Delirium, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 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 31 Jul 2007. 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 Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Development of postoperative delirium within 7 days after cardiac surgery. 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 31 Jul 2007.