Melatonin, delirium, prevention, hipfractures Melatonine, delirium, preventie, heupfracturen
Conditions
Interventions
After informed consent and after surgical repair of the hip fracture, patients are randomized to receive melatonin 3 mg or placebo in the evening with a maximum of 5 days. After reaching g the primar
Sponsors
S.E. de Rooij / Academic Medical Centre Amsterdam
Academic Medical Center
Meibergdreef 9
1105 AZ Amsterdam
The Netherlands
Tel. (31)205665991
Fax (31)205669325
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 65 yrs or older 2. Unplanned surgical repair of hip or femoral fracture 3. Patients must be willing and medically able to receive therapy according to the protocol for the duration of the study
Exclusion criteria
Exclusion criteria: 1. Age: under 65 yrs 2. Delirium:pre-operative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint will be the occurrence of POD diagnosed with the Confusion Assessement Method (CAM-score) within 5 days after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Whether visual assessment of SPECT scans may reveal perfusion abnormalities in frontal or parietal cerebral perfusion abnormalities in patients with and without POD using placebo and in (non)-delirious patients using melatonin. 2. Differences in plasma melatonin concentrations in delirious and non-delirious patients using placebo and in patients using melatonin 3. Severity and duration of POD in placebo and melatonin group 4. Both hospital and post-discharge complications in (non) delirious patients using placebo and melatonin | — |
Contacts
Public ContactH.E. Oosten, van
Academic Medical Center Meibergdreef 9
Outcome results
None listed