|- candidate number||4651|
|- NTR Number||NTR1576|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-dec-2008|
|- Secondary IDs||EudraCT 2008-000996-57|
|- Public Title||MAPLE A
(Melatonin Against PLacebo in Elderly patients).|
|- Scientific Title||The Effects of melatonin versus placebo on the occurence of delirium in hip fracture patients - a randomized, placebo controlled, double-blind trial.|
|- ACRONYM||MAPLE A|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Delirium, Elderly patients, Hip fractures|
|- 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.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-nov-2008|
|- planned closingdate|
|- Target number of participants||340|
|- Interventions||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.|
|- 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.
|- Timepoints||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.
|- Trial web site||none|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. S.E. Rooij, de|
|- CONTACT for SCIENTIFIC QUERIES||Dr. S.E. Rooij, de|
|- Sponsor/Initiator ||Academic Medical Center (AMC) - Internal Geriatric Department |
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC) - Internal Geriatric Department |
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||2-dec-2008 - 9-aug-2013|