delirium, medically-ill, elderly patients. delier, interne-aandoeningen, oudere patienten.
Conditions
Interventions
patients receive anti-psychotics and melatonin or antipsychotics and placebo.
Sponsors
Academic Medical Center
Amsterdam
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate possible differences in duration of delirium between patients receiving either anti-psychotics + melatonin or anti-psychotics + placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactS.E. Rooij, de
Academic Medical Centre Amsterdam Internal-Geriatric Department Academic Medical Center Meibergdreef 9
Outcome results
None listed