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

July 27, 2015 updated by: Eline Vandael, KU Leuven

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

Study Type

Observational

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients treated with acute potentional QT-prolonging medication. In a university hospital.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients treated with a potentional QT-prolonging 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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 21, 2014

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.

Clinical Trials on Delirium

3
Subscribe