To study whether rivastigmine added to treatment with haloperidol shortens the duration of delirium in ICU patients and reduces costs.
ID
Source
Brief title
Condition
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Duration of delirium during hospital admission (i.e. at the ICU and at the ward
combined). This will be assessed by the sum of the duration of ICU delirium
(defined as the number of hours that the CAM-ICU is positive), and the duration
of delirium at a ward with lower level of care (defined as the number of hours
that the CAM is positive).
Secondary outcome
1. Severity of delirium as assessed with the DSI. 2. The number of times rescue
medication is given in case of severe agitation, as well as the total dose of
haloperidol and propofol. 3. The number and type of accidentally removed
catheters. 4. Use of physical restraints. 5. Frequency and distribution of
possible adverse effects. 6. Length of ICU stay.
7. The number of re-admissions to the ICU during hospital stay. 8. Length of
hospital stay.
9. Cumulative survival from inclusion in the trial until 90 days. 10.
Activities of daily living 90 days after inclusion in the trial. 11. Quality of
life 90 days after inclusion in the proposed study. 12. Cognitive function 90
days after inclusion in the trial.
Background summary
Delirium in the Intensive Care Unit (ICU) is a frequent disorder. It is
estimated that 70% of the patients in the ICU, will suffer an episode of
delirium during their stay in the ICU. Delirium in the ICU is not only an
unpleasant and freighting experience for the patient and their relatives,
delirium is also associated with worse prognosis (higher morbidity and
mortality) and higher costs. Diagnosing delirium in the ICU is a difficult
task, due to the frequent inability to communicate (i.e. intubation). In this
study a validated method will be used: the Confusion Assessment Method for the
ICU (CAM-ICU), a method with high sensitivity and specificity. The current
therapy for (ICU-) delirium is treatment of the underlying condition (e.g.
urinary tract infection) and symptomatic treatment with haloperidol. Several
publications and clinical experience of the investigators have shown that
rivastigmine (a cholinesterase inhibitor) may have a positive effect on the
duration of delirium in delirious patients.
Study 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, placebo-controlled, add-on trial.
Intervention
Delirious patients will receive the usual treatment (haloperidol). Subjects
will be randomized between two groups: the intervention group and the placebo
group.
Intervention group: 1,5 mg. rivastigmine twice daily. This 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 is reached.
Placebo group: twice a day, same dosage scheme as above.
Study burden and risks
Burden: Evaluation of the cognitive functions of the participants (using the
CAM-ICU) will be conducted as part of the daily practice. Fur study purposes
only; the participant (and the legal representative) will be assessed at base
line (duration: 10 minutes), and 90 days after inclusion for among others ADL
and QoL (duration: 20 minutes).
Risk: Participants are at risk of being treated with a drug, not-indicated for
their disorder. This drug (rivastigmine) however is extensively tested on
humans, and the investigators of this study have extensive clinical experience
with *off label* prescription of this medication for delirium. Several
publications indicate that rivastigmine might have a positive effect on the
duration of delirium.
Benefit: Participants may be treated with a medication of which the experts
believe that it will positively affect the prognosis.
Consideration: The investigators of this study believe that the burden and risk
do not exceed the benefit.
Postbus 85500
3508 GA, Utrecht
Nederland
Postbus 85500
3508 GA, Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
1. 18 years or older
2. Positive CAM-ICU
3. Anticipated ICU and/or Medium Care length of stay >48 hours
Exclusion criteria
1. Known allergy to rivastigmine
2. Unable to receive enteric medication
3. Pregnant or lactating
4. Renal replacement therapy
5. Hepatic encephalopathy
6. Second or third degree atrioventricular block
7. Uncertainty about diagnosis delirium and no confirmation by neurologist, psychiatrist or geriatrician
8. Bradycardia with hemodynamic consequences (without functioning pacemaker)
9. No informed consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-005300-41-NL |
| ClinicalTrials.gov | NCT00704301 |
| CCMO | NL19821.041.08 |