Drug Interactions With Risk of QT-prolongation in a General Hospital

June 10, 2014 updated by: Eline Vandael, KU Leuven

Drug Interactions With Risk of QT-prolongation in a General Hospital: an Epidemiological Point Prevalence Study

In this epidemiological point prevalence study, medication profiles of patients with haloperidol treatment will be checked for drug interactions with risk of QT-prolongation. Additional clinical risk factors for developing QT-prolongation and safety measurements will be documented.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design: epidemiological point prevalence study

Target population: Patients with haloperidol treatment

The following aspects will be investigated:

  • The medication profiles will be checked for drug interactions with risk of QT-prolongation.
  • Clinical risk factors for developing QT-prolongation (gender, age, (history of) cardiovascular disease, comorbidity,...) and lab results will be collected.
  • Safety measurements (e.g. ECG) will be documented.

Study Type

Observational

Enrollment (Actual)

222

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

  • Belgium
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients who are treated with haloperidol (every tuesday we will make a selection of the patients who received haloperidol on monday)

Description

Inclusion Criteria:

  • treatment with haloperidol (started in the hospital)

Exclusion Criteria:

  • age < 18 years

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients treated with haloperidol
Drug: Haloperidol
Other Names:
  • Haldol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
QTc-interval (corrected for heart rate)
Time Frame: maximum one year before inclusion / one week after inclusion
maximum one year before inclusion / one week after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
number of drug interactions (with risk of QT-prolongation)
Time Frame: one week before/after inclusion
one week before/after inclusion

Other Outcome Measures

Outcome Measure
Time Frame
number of patients with an ECG before or after the start of haloperidol
Time Frame: maximum one year before inclusion / one week after inclusion
maximum one year before inclusion / one week after inclusion

Collaborators and Investigators

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

Sponsor

KU Leuven

Collaborators

Agentschap voor Innovatie door Wetenschap en Technologie

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

July 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

June 11, 2014

Last Update Submitted That Met QC Criteria

June 10, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EV002

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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