Acute cardiometabolic risks during treatment with haloperidol in elderly patients.

Withdrawn

• Conditions: side effect; 10012221

• Registration Number: NL-OMON37239
• 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• Status: Withdrawn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: 128

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

- 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

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).<br /><br>b. QTc-prolongation measured by (holter) ECG using Fridericia*s formula .</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Serum level of triglycerides (mmol/l).<br /><br>2. Closure time (sec), measured by Platelet Functional Analyser (PFA-100).<br /><br>3. Serum concentration haloperidol (*g/L).<br /><br>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>