DeliriumPhase 4NCT00704301
Rivastigmine for Intensive Care Unit (ICU) Delirium
A Phase 4 study testing Rivastigmine in people with Delirium, run by UMC Utrecht at 6 sites in Netherlands.
Trial summary
Delirium in Intensive Care (IC) patients is a frequent disorder. The aim of this study is to investigate whether treatment of delirium in the ICU with rivastigmine added to haloperidol shortens the duration of delirium in comparison to placebo added to the treatment with haloperidol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Rivastigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 6 sitesNetherlands
- Study dates
- Nov 2008to May 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Positive CAM-ICU
Who cannot join
- Known allergy to rivastigmine
- Unable to receive enteric medication
- Pregnant or lactating
- Renal replacement therapy
- Hepatic encephalopathy
- Second or third degree atrioventricular block
Show all 11Show fewer
- Uncertainty about diagnosis delirium and no confirmation by neurologist, psychiatrist or geriatrician
- Parkinson's disease.
- Lewy body dementia.
- ECG QT interval above 500 msec.
- No informed consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Medical Center Alkmaar
Alkmaar, North Holland, 1800 AM
Gelre Hospitals; lukas site
Apeldoorn, Gelderland, 7300 DS
Medical Center Leeuwarden
Leeuwarden, Provincie Friesland, 8901 BR
Erasmus Medical Center
Rotterdam, South Holland, 3000 CA
University Medical Center Utrecht
Utrecht, Utrecht, 3508 GA
Diakonessenhuis
Utrecht, Utrecht, 3582 KE
About this study
Official title: Rivastigmine for Delirium in Intensive Care Patients, a Double-blind, Randomized Placebo-controlled add-on Trial
Delirium in Intensive Care (IC) patients is a frequent disorder. The aim of this study is to investigate whether treatment of delirium in the ICU with rivastigmine added to haloperidol shortens the duration of delirium in comparison to placebo added to the treatment with haloperidol.
Read the detailed description
Objective: To study whether rivastigmine added to treatment with haloperidol shortens the duration of delirium in ICU patients and reduces costs.
Study design: Multicentre, double-blind, randomized controlled trial. Study population: Consecutive adult ICU patients with delirium according to the CAM-ICU.
Intervention: Increasing dosage of rivastigmine or placebo as add-on medication.
Primary study parameters: Duration of delirium. Secondary study parameters: Delirium severity, length of ICU and hospital stay, functional status and mortality after 3 months.
Sample size: 440 patients will be included. Economic evaluation: includes a comparison of direct and indirect medical costs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Burden: questionnaires (duration: 30 minutes). Risk: possible exposure to drug not indicated for the disorder. Benefit: possible treatment with according to experts possible beneficial drug. Consideration: The investigators of this study believe that the burden and risk do not exceed the expected benefit.
- Conditions
- Delirium
- Being tested
- Rivastigmine, Placebo
- Keywords
- Delirium, Confusion
- Medical subject headings
- Delirium, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivastigmineDrug
Also called Exelon
Rivastigmine, two times 1,5 mg a day. The dosage will be increased every three days with 3 mg a day, until the CAM-ICU is negative or until the occurrence of presumed severe adverse effects or until a maximum of 12 mg a day.
PlaceboDrug
Placebo, 2 times a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Haloperidol: aged 70 years or less: 1 mg haloperidol three times a day i.v. older than 70 years: 0,5 mg haloperidol three times a day i.v. Rivastigmine: two times 1,5 mg a day; The dosage will be increased every three days with 3 mg a day, until the CAM-ICU is negative or until the occurrence of presumed severe adverse effects or until a maximum of 12 mg a day. Receives: Drug: Rivastigmine |
| 2 | Placebo comparator | Haloperidol: aged 70 years or less: 1 mg haloperidol three times a day i.v. older than 70 years: 0,5 mg haloperidol three times a day i.v. Placebo: 2 times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of delirium
Measured: 3 months
Secondary outcomes (10)
Severity of delirium
Measured: 3 months
Use of physical restraints
Measured: 3 months
Use of escape medication (i.c. Haloperidol or benzodiazepines)
Measured: 3 months
Number of accidental removed catheters
Measured: 3 months
Length of ICU stay
Measured: 3 months
Length of in-hospital stay
Measured: 3 months
Cognitive outcomes
Measured: 3 months
Activity of daily living
Measured: 3 months
Healthcare costs
Measured: 3 months
Frequency and distribution of side effects
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2010
- Study completionMay 2010
Why it stopped: The study is prematurely terminated due to a safety issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Novartis, Netherlands Brain Foundation
- Investigators
- Arjen JC Slooter, MD. PhD., Principal investigator, University Medical Center Utrecht, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704301
- Sponsor's protocol ID
- IC-DEL/009
- Status last verified
- Oct 2009
- First submitted
- 20 Jun 2008
- Last updated
- 13 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Eijk MM, Roes KC, Honing ML, Kuiper MA, Karakus A, van der Jagt M, Spronk PE, van Gool WA, van der Mast RC, Kesecioglu J, Slooter AJ. Effect of rivastigmine as an adjunct to usual care with haloperidol on duration of delirium and mortality in critically ill patients: a multicentre, double-blind, placebo-controlled randomised trial. Lancet. 2010 Nov 27;376(9755):1829-37. doi: 10.1016/S0140-6736(10)61855-7. Epub 2010 Nov 4.
PubMed 21056464
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivastigmine for Delirium in Intensive Care Patients, a Double-blind, Randomized Placebo-controlled add-on Trial
- ClinicalTrials.gov ID
- NCT00704301
- Acronym / sponsor ID
- IC-DEL/009
- Conditions
- Delirium
- Keywords
- Delirium, Confusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is prematurely terminated due to a safety issue
- Enrolment
- 104 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Novartis, Netherlands Brain Foundation
- Study start
- Nov 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 Jun 2008 (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 in Intensive Care (IC) patients is a frequent disorder. The aim of this study is to investigate whether treatment of delirium in the ICU with rivastigmine added to haloperidol shortens the duration of delirium in comparison to placebo added to the treatment with haloperidol.
Detailed description
Objective: To study whether rivastigmine added to treatment with haloperidol shortens the duration of delirium in ICU patients and reduces costs.
Study design: Multicentre, double-blind, randomized controlled trial. Study population: Consecutive adult ICU patients with delirium according to the CAM-ICU.
Intervention: Increasing dosage of rivastigmine or placebo as add-on medication.
Primary study parameters: Duration of delirium. Secondary study parameters: Delirium severity, length of ICU and hospital stay, functional status and mortality after 3 months.
Sample size: 440 patients will be included. Economic evaluation: includes a comparison of direct and indirect medical costs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Burden: questionnaires (duration: 30 minutes). Risk: possible exposure to drug not indicated for the disorder. Benefit: possible treatment with according to experts possible beneficial drug. Consideration: The investigators of this study believe that the burden and risk do not exceed the expected benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RivastigmineHaloperidol: aged 70 years or less: 1 mg haloperidol three times a day i.v. older than 70 years: 0,5 mg haloperidol three times a day i.v. Rivastigmine: two times 1,5 mg a day; The dosage will be increased every three days with 3 mg a day, until the CAM-ICU is negative or until the occurrence of presumed severe adverse effects or until a maximum of 12 mg a day. |
| 2 | Placebo comparator | Drug: PlaceboHaloperidol: aged 70 years or less: 1 mg haloperidol three times a day i.v. older than 70 years: 0,5 mg haloperidol three times a day i.v. Placebo: 2 times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Positive CAM-ICU
Key exclusion criteria (11 listed)
- Known allergy to rivastigmine
- Unable to receive enteric medication
- Pregnant or lactating
- Renal replacement therapy
- Hepatic encephalopathy
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 |
|---|---|---|
| RivastigmineAlso: ExelonRivastigmine, two times 1,5 mg a day. The dosage will be increased every three days with 3 mg a day, until the CAM-ICU is negative or until the occurrence of presumed severe adverse effects or until a maximum of 12 mg a day. | Drug | 1 |
| PlaceboPlacebo, 2 times a day | Drug | 2 |
Primary outcome
Duration of delirium
Time frame: 3 months
10 secondary outcomes
Severity of delirium
Time frame: 3 months
Use of physical restraints
Time frame: 3 months
Use of escape medication (i.c. Haloperidol or benzodiazepines)
Time frame: 3 months
Number of accidental removed catheters
Time frame: 3 months
Length of ICU stay
Time frame: 3 months
Length of in-hospital stay
Time frame: 3 months
Cognitive outcomes
Time frame: 3 months
Activity of daily living
Time frame: 3 months
Healthcare costs
Time frame: 3 months
Frequency and distribution of side effects
Time frame: 3 months
Results and safety
The study was stopped early (reason given: The study is prematurely terminated due to a safety issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2010.
- Derived from this study: PubMed 21056464van Eijk MM, Roes KC, Honing ML, Kuiper MA, Karakus A, van der Jagt M, Spronk PE, van Gool WA, van der Mast RC, Kesecioglu J, Slooter AJ. Effect of rivastigmine as an adjunct to usual care with haloperidol on duration of delirium and mortality in critically ill patients: a multicentre, double-blind, placebo-controlled randomised trial. Lancet. 2010 Nov 27;376(9755):1829-37. doi: 10.1016/S0140-6736(10)61855-7. Epub 2010 Nov 4.
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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.
Arjen JC Slooter, MD. PhD. principal investigator
University Medical Center Utrecht, the Netherlands
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivastigmine in people with Delirium, run by UMC Utrecht at 6 sites in Netherlands.
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 11 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 13 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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. Some participants in this study may receive a placebo. 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: The study is prematurely terminated due to a safety issue). 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?
Duration of delirium (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00704301, which also lists 1 linked publication.
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 13 Aug 2010.