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

Information source: Katholieke Universiteit Leuven
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Delirium; QT-prolongation

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

Phase: N/A

Status: Completed

Sponsored by: Katholieke Universiteit Leuven

Official(s) and/or principal investigator(s):
Eline Vandael, PhD-student, Principal Investigator, Affiliation: Katholieke Universiteit Leuven


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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: change in QTc-interval (corrected for heart rate)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

UZ Leuven, Leuven 3000, Belgium
Additional Information

Starting date: February 2014
Last updated: July 27, 2015

Page last updated: August 23, 2015

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