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Acute cardiometabole risico’s tijdens de behandeling met haloperidol bij ouderen.


- candidate number13478
- NTR NumberNTR3679
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-okt-2012
- Secondary IDs12-443 METC UMCU
- Public TitleAcute cardiometabole risico’s tijdens de behandeling met haloperidol bij ouderen.
- Scientific TitleAcute cardiometabolic risks during treatment with haloperidol in elderly patients.
- ACRONYMCMH- study
- hypothesisAntipsychotics (haloperidol) can cause acute changes in cardiovascular functions, metobolic parameters and platelet aggregation in elderly patients.
- Healt Condition(s) or Problem(s) studiedOlder adults, Delirium, Antipsychotics
- Inclusion criteria1. Age 70 years and older admitted for hip fracture or other fall-related fractures;
2. Inclusion within 72 hours after admission;
3. 90 days of medication history available.
- Exclusion criteria1. Use of an antipsychotic agent within 90 days before admission;
2. Start or dose change in of any anticoagulants, Qtc prolongation drugs, antidiabetic drugs, antihypertensive drugs or cholesterol lowering drugs;
3. Terminal illness.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2012
- planned closingdate1-jun-2014
- Target number of participants128
- InterventionsN/A
- Primary outcome1. QTc- prolongation measured with holter ECG;
2. Serum NT-proBNP, glucose, triglycerides;
3. Closure time.
- Secondary outcome1. QTc- prolongation measured with ECG;
2. Serum concentration haloperidol;
3. DDD;
4. Total antipsychotic expose;
5. DNA profile.
- Timepoints1. Holter ECG: Day 3 after initiation of haloperidol;
2. ECG, serum NT-proBNP, triglycerides and closure time: Baseline and day 3-5-7;
3. Glucose: Baseline, day 0-7 (daily check);
4. Serum concentration haloperidol: Day 4 after initiation of haloperidol;
5. DNA profile: Baseline.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIES K. Keulen, van
- CONTACT for SCIENTIFIC QUERIES W. Knol
- Sponsor/Initiator Tergooiziekenhuizen
- Funding
(Source(s) of Monetary or Material Support)
Tergooiziekenhuizen
- PublicationsN/A
- Brief summaryExtrapolation of results investigating cardiometabolic side effects during antipsychotic use in the younger schizophrenic population to the elderly is difficult. This observational, prospective study is designed to extend our knowledge of acute cardiometabolic side effects during treatment with haloperidol in the elderly. Therefore we will include patients 70 years and older admitted on the department of Orthopaedics or Surgery in Tergooiziekenhuizen with hip fractures or other fall-related fractures. The cardiometabolic function in patients treated with haloperidol for a delirium will be compared with cardiometabolic function of patients without treatment with haloperidol.
- Main changes (audit trail)25-Apr-2013: METC-approval not received, trial will not be started - NM
- RECORD25-okt-2012 - 25-apr-2013


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