No registrations found.
ID
Source
Brief title
Health condition
delirium, medically-ill, elderly patients.
delier, interne-aandoeningen, oudere patienten.
Sponsors and support
Amsterdam
Intervention
Outcome measures
Primary outcome
Evaluate possible differences in duration of delirium between patients receiving either anti-psychotics + melatonin or anti-psychotics + placebo.
Secondary outcome
1. Evaluate possible differences in severity of delirium between the anti-psychotics + melatonin group and the anti-psychotics + placebo group;
2. Compare possible differences in the length of hospital stay in delirious patients in the anti-psychotic + melatonin group or anti-psychotic + placebo group;
3. Evaluate possible differences in the total dose of additional benzodiazepines used to treat delirium in both the anti-psychotics + melatonin group and the anti-psychotics + placebo group;
4. Evaluate possible differences in the total dose of haloperidol used during the period of delirium in the anti-psychotics + melatonin group and the anti-psychotics + placebo group;
5. Evaluate the possible effects of delirium and of melatonin therapy on cognitive function 3 months and 12 months after hospital admission;
6. Evaluate possible effects of delirium and of melatonin therapy on functional decline, measured by grip-strength and by KATZ questionnaire.
Background summary
N/A
Study objective
To compare the differences in duration of delirium in delirious patients receiving anti-psychotic therapy + melatonin or anti-psychotic therapy + placebo.
Study design
During admission on each day of the study until the delirium is resolved with a maximum of twelve days. Three months and twelve months after discharge from the hospital.
Intervention
patients receive anti-psychotics and melatonin or antipsychotics and placebo.
Internal-Geriatric Department
Academic Medical Center
Meibergdreef 9
S.E. Rooij, de
Amsterdam 1105 AZ
The Netherlands
(31)205669325
Internal-Geriatric Department
Academic Medical Center
Meibergdreef 9
S.E. Rooij, de
Amsterdam 1105 AZ
The Netherlands
(31)205669325
Inclusion criteria
1. Age 65 years or older;
2. Acute hospital admission at medical ward;
3. Patients diagnosed with delirium for which anti-psychotic therapy is needed;
4. Patients must be willing and medically able to receive therapy according to the protocol for the duration of the study;
5. Written informed consent must be obtained.
Exclusion criteria
1. Patients on medication that can’t speak or understand Dutch;
2. Patients diagnosed with delirium who have received anti-psychotics longer than 24 hours;
3. Patients with a clinical diagnosis of hypoactive delirium.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL1578 |
| NTR-old | NTR1657 |
| Other | EudraCTnumber : 2008-006452-22 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |