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

NCT02068170 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 178

Last updated 2015-07-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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

Sponsors & Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie

    collaborator OTHER

  • KU Leuven

    lead OTHER

Principal Investigators

  • Eline Vandael, PhD-student · KU Leuven

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-03-31
Completion
2015-06-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02068170 on ClinicalTrials.gov