Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital (RISQ-PATH)

Catholic University (KU) of Leuven

Status: Completed

Conditions: Delirium; QT-prolongation

Treatments: Drug: Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib

Study type: Observational

Funder types: Other

Identifiers

NCT02068170

EV003

Details and patient eligibility

About

A prospective, observational study in a university hospital (UZ Leuven). Patients are included when they are treated with a potentional QT-prolonging drug: haloperidol for delirium, antibiotics (moxifloxacin, levofloxacin, azithromycin, clarithromycin, erythromycin, co-trimoxazole), antimycotics (ketoconazole, itraconazole, fluconazole, voriconazole), methadone, tacrolimus and oral oncolytics.

An ECG is taken before the administration of the drug and 3-5 days after starting the drug to investigate the change in duration of the QTc-interval. Risk factors for developing QT-prolongation will be documented. Together with ECG2, an additional blood sample will be collected to measure the blood concentration of the drug.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• treatment with a potentional QT-prolonging drug of our list
• inpatient of UZ Leuven, admitted on one of the participating wards

Exclusion criteria

• < 18 years old
• DNR-code 3
• not possible to take an ECG before the start of haloperidol

Trial design

178 participants in 1 patient group

patients treated with a potentional QT-prolonging drug

Treatment:

Drug: Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib