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

Completed

• Conditions: Delirium; QT-prolongation
• Interventions: Drug: Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib

• Registration Number: NCT02068170
• Lead Sponsor: KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-21
• Primary Completion: 2015-03
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients treated with a potentional QT-prolonging drug	Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib	-

Primary Outcome Measures

Name	Time	Method
change in QTc-interval (corrected for heart rate)	before and 3-5 days after the start of a potentional QT-prolonging drug

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium