- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02068170
Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital (RISQ-PATH)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- UZ Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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patients treated with a potentional QT-prolonging drug
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in QTc-interval (corrected for heart rate)
Time Frame: before and 3-5 days after the start of a potentional QT-prolonging drug
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before and 3-5 days after the start of a potentional QT-prolonging drug
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Congenital Abnormalities
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Tachycardia, Ventricular
- Tachycardia
- Torsades de Pointes
- Long QT Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Analgesics, Opioid
- Narcotics
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Dopamine Agents
- Dopamine Antagonists
- Protein Kinase Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Respiratory System Agents
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Antitussive Agents
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Calcineurin Inhibitors
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C19 Inhibitors
- Sunitinib
- Moxifloxacin
- Norgestimate, ethinyl estradiol drug combination
- Erythromycin
- Erythromycin Estolate
- Erythromycin Ethylsuccinate
- Erythromycin stearate
- Ketoconazole
- Clarithromycin
- Tacrolimus
- Itraconazole
- Azithromycin
- Haloperidol
- Haloperidol decanoate
- Levofloxacin
- Hydroxyitraconazole
- Fluconazole
- Trimethoprim, Sulfamethoxazole Drug Combination
- Methadone
- Voriconazole
Other Study ID Numbers
- EV003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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