To evaluate whether preventive treament with haloperidol lowers the risk for delirium in stroke patients with an increased risk for delirium.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
occurence of delirium
Secondary outcome
Duration of delirium
Severity of delirium
Duration of admission
Score on Modified Rankin Scale at discharge
Discharge place (home, rehabilitation center, nursing home)
Mortality and morbidity at discharge, and six weeks and one year after
discharge
Background summary
Delirium is a common complication in hospitalized patients. The estimated
incidence of delirium in stroke patients is 13-48%. Delirium is associated with
increased morbidity, mortality and a longer duration of hospitalization. There
are no prospective studies on preventive treatment with haloperidol in stroke
patients.
The current study is a placebo controlled dubbelblinded randomized trial on
preventive treatment with haloperidol in stroke patients with an increased risk
for delirium. Patients admitted with an acute stroke are eligible for this
study. The risk for delirium will be estimated based on several predisposing
factors for delirium (age>75 years, co-morbidity, preexistent cognitive
decline, visual or auditory problems, ADL-depency).
Treatment consists of haloperidol 1 mg three times daily for three days. If a
delirium occurs during the first three days of admission the study is ended and
the patient will be treated according to the current guidelines for delirum.
Participants will be asked to complete several questionnaires on admission and
the following 4 days. Several questionnaires are already standard in stroke
patients admitted to a stroke unit.
The tests are: DSM-IV criteria for delirum, Confusion Assessment Method (CAM),
Confusion Assessment Method for the ICU (CAM-ICU), Delirium Rating Scale (DRS),
IQCODE-N, Groningen Frailty Indicator, Mini Mental State Examinations (MMSE),
Delirium Observation Screening (DOS), Delier-O-meter (DOM), NIHSS score,
Oxfordshire Community Stroke Project (OCSP) criteria, Barthel Index en Modified
Rankin Scale. Most scales are filled in at admission (extra time for patient 15
minutes). The first four days of admission the following scales will be filled
in: CAM, CAM-ICU, DOS en DOM; DRS en DSM-IV criteria if a delirum is present
(extra time 5 minutes per day).
On admission routine laboratory investigations are performed in all patients.
At this routine laboratory examination and at day two 10 ml EDTA blood will be
drawn and stored anomised for analyses of cytokine profiles. During the first
for days the patient will wear an actimeter (sort of watch) at the non-dominant
wrist to register movement activity.
Stroke patients are routinely revised 6 weeks after discharge. At this visit
the MMSE, CAM, CAM-ICU and DRS will be filled in(10 minutes). If consent is
given an extra visit is planned one year after discharge to repeat these
measures (10 minutes).
Study objective
To evaluate whether preventive treament with haloperidol lowers the risk for
delirium in stroke patients with an increased risk for delirium.
Study design
Placebo controlled dubbelblinded trial
Intervention
Haloperidol 1 mg 3 times daily for three days.
Study burden and risks
The nature and extent of the burden and risks associated with participation is
low.
The potential benifit of participation is high.
Boerhaavelaan 22
2035 RC Haarlem
Nederland
Boerhaavelaan 22
2035 RC Haarlem
Nederland
Listed location countries
Age
Inclusion criteria
- Patients with (suspected) stroke
- no delirium on admission (DRS<12; CAM < 2+1)
- expected duration of hospitalisation >48 hours
- Score on deliersticker * 5
- Time between admission and estimation of risk score and DRS/CAM < 24 hours
Exclusion criteria
- Score deliersticker < 5
- delirium on admission (DRS> 12; CAM * 2+1; CAM-ICU * 2 + 1)
- not able to perform delirum screening (DRS, CAM, CAM-ICU) on admission
- expected duriong of hospitalisation < 48 uur
- contraindication for use of haloperidol: history of allergy for haloperidol, severe liverinsufficiency, Parkinson's disease, Lewy body dementia, parkinsonism, epilepsy, use of levodopa/dopamine agonist, use of antipsychotics (e.g., haloperidol) or cholinesterase inhibitors
- Pronged Qt interval: Qt interval on EKG on admission * 500ms .
- Time between admission and estimation of risk score and DRS/CAM < 24 hours
- Participation in same study in the last three months
- severe impairment of consciousness (coma)
- not possible to obtain informed consent
- Patients, family of physician refuse to participate
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 | EUCTR2009-015604-25-NL |
| CCMO | NL29469.094.09 |