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
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.
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)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
UZ Leuven, Leuven 3000, Belgium
Additional Information
Starting date: February 2014
Last updated: July 27, 2015
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