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

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.

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Key information

Conditions

Delirium Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Abnormalities Cardiovascular Diseases Confusion Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Long QT Syndrome Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms QT-prolongation Signs and Symptoms Tachycardia Tachycardia, Ventricular Torsades de Pointes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib

Drug

Other names: haloperidol: Haldol, ATC-code: N05AD01, azithromycin: Zitromax, ATC-code: J01FA10, clarithromycin: Biclar, ATC-code: J01FA09, erythromycin: Erytroforte, ATC-code: J01FA01, levofloxacin: Tavanic, ATC-code: J01MA12, moxifloxacin: Avelox, ATC-code: J01MA14, co-trimoxazole: Bactrim, Eusaprim, ATC-code: J01EE01, voriconazole: Vfend, ATC-code: J02AC03, ketoconazole: Nizoral, ATC-code: J02AB02, fluconazole: Diflucan, ATC-code: J02AC01, itraconazole: Sporanox, ATC-code: J02AC02, methadone: ATC-code: N07BC02, tacrolimus: Prograft, Advagraft, ATC-code: L04AD02, sunitinib: Sutent, ATC-code: L01XE04

Primary outcomes

change in QTc-interval (corrected for heart rate)

Time frame: before and 3-5 days after the start of a potentional QT-prolonging drug

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

Agentschap voor Innovatie door Wetenschap en Technologie

Registry information

Acronym: RISQ-PATH

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Feb 21, 2014
Registry last updated: Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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