Acute cardiometabolic adverse effects during treatment with haloperidol in elderly patients

Withdrawn

• Conditions: adverse effect; 10012221

• Registration Number: NL-OMON38934
• Lead Sponsor: Tergooiziekenhuizen Hilversum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 150

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>a. Serum level of fastening glucose (mmol/l). b. QT interval measured by<br /><br>(holter) ECG using Fridericia*s formula . </p><br>

Secondary Outcome Measures

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