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Acute cardiometabolic risks during treatment with haloperidol in elderly patients.

Acute cardiometabolic risks during treatment with haloperidol in elderly patients. - CMH- study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37239
Enrollment
128
Registered
2013-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

side effect

Interventions

None listed

Sponsors

Tergooiziekenhuizen Hilversum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age 70 years and older - Admission on the department of Orthopedics or Surgery for hip fracture or other fall-related-fractures - Exclusion within 24 hours after admission on the department - The patient or representative speaks either Dutch or English - Patient or representative must be able to give informed consent

Exclusion criteria

Exclusion criteria: - Use of an antipsychotic agent within 90 days before hospital admission - Start or dose changes in anticoagulant drugs, drugs related to QTc-prolongation, antidiabetic, antihypertensive or cholesterol lowering drugs in the 14 days before admission Additional for subgroup 1: - History of a pacemaker implantation, atrial fibrillation, bundle branch block, congenital Qt- syndrome - Use of QT prolongating drugs (Cert list 1 www.azcert.org) in the 14 days before admission

Design outcomes

Primary

MeasureTime frame
a. Serum level of fastening glucose (mmol/l). b. QTc-prolongation measured by (holter) ECG using Fridericia*s formula .

Secondary

MeasureTime frame
1. Serum level of triglycerides (mmol/l). 2. Closure time (sec), measured by Platelet Functional Analyser (PFA-100). 3. Serum concentration haloperidol (*g/L). 4. Daily defined dose, total antipsychotic exposure in haloperidol users. 5. Genetic polymorphisms at D2 receptor, serotonin 2c receptor, methylenetetrahydrofolate reductase (MTHFR), NUBPL and NOS1AP genes.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)