No registrations found.
ID
Source
Brief title
Health condition
ouderen, delier, antipsychotica
elderly, delirium, antipsychotics
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. QTc- prolongation measured with holter ECG;
2. Serum NT-proBNP, glucose, triglycerides;
3. Closure time.
Secondary outcome
1. QTc- prolongation measured with ECG;
2. Serum concentration haloperidol;
3. DDD;
4. Total antipsychotic expose;
5. DNA profile.
Background summary
Extrapolation 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.
25-Apr-2013: METC-approval not received, trial will not be started.
Study objective
Antipsychotics (haloperidol) can cause acute changes in cardiovascular functions, metobolic parameters and platelet aggregation in elderly patients.
Study design
1. 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.
Intervention
N/A
Postbus 10016
K. Keulen, van
Hilversum 1201 DA
The Netherlands
-
kvankeulen@tergooiziekenhuizen.nl
Postbus 10016
K. Keulen, van
Hilversum 1201 DA
The Netherlands
-
kvankeulen@tergooiziekenhuizen.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
IPD sharing statement
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 | NL3517 |
| NTR-old | NTR3679 |
| Other | METC UMCU : 12-443 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |