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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Katholieke Universiteit Leuven; KU Leuven
• Collaborator: Agentschap voor Innovatie door Wetenschap en Technologie
• Treatments: Azithromycin; Clarithromycin; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Fluconazole; Fluoroquinolones; Haloperidol; Haloperidol decanoate; Hydroxyitraconazole; Itraconazole; Ketoconazole; Levofloxacin; Methadone; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Sunitinib; Tacrolimus; Trimethoprim, Sulfamethoxazole Drug Combination; Voriconazole

Criteria

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