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Acute cardiometabolic adverse effects during treatment with haloperidol in elderly patients

Acute cardiometabolic adverse effects during treatment with haloperidol in elderly patients - CMH- study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38934
Enrollment
150
Registered
2013-07-19
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

adverse effect

Interventions

None listed

Sponsors

Tergooiziekenhuizen Hilversum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 70 years or older. Admitted for a hip fracture or other fall- related fracture on the department of Surgery or Orthopaedics. Inclusion 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. Patient is not undergoing surgery for the hip fracture or other fall- related fracture. Start or dose changes in the following medication in the 14 days before admission: Thrombocyte aggregation inhibitors QT- prolongating drugs Antidiabetic drugs Antihypertensive drugs Cholesterol- lowering drugs Additional for recording a holter electrocardiogram (ECG) for patients in subgroup 1: History of 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. QT interval 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 (µg/ 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)