No registrations found.
ID
Source
Brief title
Health condition
Melatonin, delirium, prevention, hipfractures
Melatonine, delirium, preventie, heupfracturen
Sponsors and support
Academic Medical Center
Meibergdreef 9
1105 AZ Amsterdam
The Netherlands
Tel. (31)205665991
Fax (31)205669325
Intervention
Outcome measures
Primary outcome
Primary endpoint will be the occurrence of POD diagnosed with the Confusion Assessement Method (CAM-score) within 5 days after surgery.
Secondary outcome
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
Study objective
Treatment with 3 mg melatonin daily will reduce the incidence of postoperative delirium in patients with hipfractures over 65 years of age.
Study design
Patiente will be included before surgical treatment for hip- or femoral fracture.
Melatonin will be given once daily for day 1 untill day 5 postoperative.
We will measure melatonin bloodlevels on day 2 and day 5 postoperative.
Intervention
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 primary endpoint, ie delirium, the patient will start with haloperidol and treatment with melatonin or placebo will be ended.
Meibergdreef 9
H.E. Oosten, van
Dept. of Internal Medicine, F4-159
section of Geriatric Medicine
Amsterdam 1105 AZ
The Netherlands
(31)205665991
hvanoosten@gmail.com
Meibergdreef 9
H.E. Oosten, van
Dept. of Internal Medicine, F4-159
section of Geriatric Medicine
Amsterdam 1105 AZ
The Netherlands
(31)205665991
hvanoosten@gmail.com
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
1. Age: under 65 yrs
2. Delirium:pre-operative
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 | NL1180 |
| NTR-old | NTR1225 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |