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MAPLE A (Melatonin Against PLacebo in Elderly patients).


- candidate number4651
- NTR NumberNTR1576
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-dec-2008
- Secondary IDsEudraCT 2008-000996-57
- Public TitleMAPLE A (Melatonin Against PLacebo in Elderly patients).
- Scientific TitleThe Effects of melatonin versus placebo on the occurence of delirium in hip fracture patients - a randomized, placebo controlled, double-blind trial.
- ACRONYMMAPLE A
- hypothesisHypothesis is that elderly patients, acutely admitted for hip fracture, treated with melatonin for 5 days will experience less delirium than patients treated with placebo.
- Healt Condition(s) or Problem(s) studiedDelirium, Elderly patients, Hip fractures
- Inclusion criteria1. 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 criteria1. Patients who can't speak / understand Dutch;
2. Patients transferred for surgical repair from another hospital.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-nov-2008
- planned closingdate
- Target number of participants340
- InterventionsPatients 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.
- Primary outcomeDelirium diagnosed within 8 days after start of the study medication.
- Secondary outcome1. 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.
- TimepointsAt 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.
- Trial web sitenone
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. S.E. Rooij, de
- CONTACT for SCIENTIFIC QUERIESDr. S.E. Rooij, de
- Sponsor/Initiator Academic Medical Center (AMC) - Internal Geriatric Department
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC) - Internal Geriatric Department
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD2-dec-2008 - 9-aug-2013


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