Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital
NCT ID: NCT02068170
Last Updated: 2015-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
178 participants
OBSERVATIONAL
2014-02-28
2015-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients treated with a potentional QT-prolonging drug
Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib
Interventions
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Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* inpatient of UZ Leuven, admitted on one of the participating wards
Exclusion Criteria
* DNR-code 3
* not possible to take an ECG before the start of haloperidol
18 Years
ALL
No
Sponsors
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Agentschap voor Innovatie door Wetenschap en Technologie
OTHER
KU Leuven
OTHER
Responsible Party
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Eline Vandael
PhD-student
Principal Investigators
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Eline Vandael, PhD-student
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
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UZ Leuven
Leuven, , Belgium
Countries
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References
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Vandael E, Vandenberk B, Vandenberghe J, Spriet I, Willems R, Foulon V. Development of a risk score for QTc-prolongation: the RISQ-PATH study. Int J Clin Pharm. 2017 Apr;39(2):424-432. doi: 10.1007/s11096-017-0446-2. Epub 2017 Mar 9.
Other Identifiers
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EV003
Identifier Type: -
Identifier Source: org_study_id
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