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The effects of melatonin versus placebo on post-operative delirium (POD) in hip fracture patients a randomized double-blind trial


- candidate number3063
- NTR NumberNTR1225
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mrt-2008
- Secondary IDs 
- Public TitleThe effects of melatonin versus placebo on post-operative delirium (POD) in hip fracture patients a randomized double-blind trial
- Scientific TitleThe effects of melatonin versus placebo on post-operative delirium (POD) in hip fracture patients a randomized double-blind trial
- ACRONYMMAPLE
- hypothesisTreatment with 3 mg melatonin daily will reduce the incidence of postoperative delirium in patients with hipfractures over 65 years of age.
- Healt Condition(s) or Problem(s) studiedDelirium, Prevention, Hip fractures, Melatonin
- Inclusion criteria1. 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 criteria1. Age: under 65 yrs
2. Delirium:pre-operative
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2008
- planned closingdate1-mei-2010
- Target number of participants175
- InterventionsAfter 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.
- Primary outcomePrimary endpoint will be the occurrence of POD diagnosed with the Confusion Assessement Method (CAM-score) within 5 days after surgery.
- Secondary outcome1. 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
- TimepointsPatiente 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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. H.E. Oosten, van
- CONTACT for SCIENTIFIC QUERIESDr. S.E. Rooij, de
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summary
- Main changes (audit trail)
- RECORD12-feb-2008 - 17-mrt-2008


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