No registrations found.
ID
Source
Brief title
Health condition
Delirium
Hip Fracture
Elderly
Sponsors and support
Intervention
Outcome measures
Primary outcome
Delirium diagnosed within 8 days after start of the study medication.
Secondary outcome
1. Severity and duration of delirium in the treatment and in the control arm.
2. Evaluate differences in subtypes of delirium in the treatment and in the control arm.
3. Evaluate differences in length of hospital stay in the treatment and in the control arm.
4. Compare the additional use of benzodiazepines during delirium in the treatment and in the control arm.
5. Compare the total dose of haloperidol used during delirium in the treatment and in the control arm.
6. Evaluate differences in in-hospital complications, defined as hospital related infections, decubitus and malnutrition in patients the treatment and in the control arm.
7. Evaluate differences in cognitive and functional decline at 12 months after hospital discharge in the treatment and in the control arm.
8. Evaluate differences in mortality during hospital stay and after 12 months follow-up in the treatment and in the control arm.
9. Evaluate differences in DNA profile in delirious and non-delirious patients.
Background summary
N/A
Study objective
Hypothesis is that elderly patients, acutely admitted for hip fracture, treated with melatonin for 5 days will experience less delirium than patients treated with placebo.
Study design
At inclusion patiente will be asked to fill in different questionaire's to asses cognitive function and activities of daily living (KATZ score, IQ-scoree, MMSE, hand-grip strenght).
At 3 months and 12 months after hospital admission patients will be visited at home for assesment of cognitive and functional decline.
Intervention
Patients included in the MAPLE A stduy will be assigned to receive either melatonin 3 mg or placebo for 5 consequtive days.
Daily check-up will take place for evaluation of delirious symptoms, using the CAM score.
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 admission for surgical repair of hip-fracture;
3. Patiente must be willing and medically able to take the study medication;
4. Patients must be able to give informed consent.
Exclusion criteria
1. Patients who can't speak / understand Dutch;
2. Patients transferred for surgical repair from another hospital.
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 | NL1506 |
| NTR-old | NTR1576 |
| Other | 2008-000996-57 : EudraCT |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |