QT-prolongation in Psychiatric Hospitals

July 27, 2015 updated by: Eline Vandael, KU Leuven
Observational study in 6 psychiatric hospitals in Flanders. Patients are included when a QT-prolonging drug is added to a medication profile that already contains a potential QT-prolonging drug. An ECG is taken before the administration of the new drug and a week after starting the new drug to investigate the change in duration of the QTc-interval. Risk factors for developing QT-prolongation and blood concentrations of potassium and creatinine are documented.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

152

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
      • Eeklo, Belgium
        • Psychiatrisch Centrum Sint-Jan

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

Observational study in 6 psychiatric hospitals in Flanders. Patients are included when a QT-prolonging drug is added to a medication profile that already contains a potential QT-prolonging drug.

Description

Inclusion Criteria:

  • inpatient in one of the 6 participating psychiatric hospitals
  • QT-prolonging drug in the medication profile and the doctor prescribes another QT-prolonging drug

Exclusion Criteria:

  • age < 18 year

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
psychiatric patients treated with QT-prolonging drugs
Drug: drugs linked with QT-prolongation
all the drugs that are mentioned in the lists of QT-prolonging drugs of CredibleMeds (www.crediblemeds.org)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in QTc-interval (corrected for heart rate)
Time Frame: before and one week after the start of a QT-prolonging drug
before and one week after the start of a QT-prolonging drug

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

October 1, 2010

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

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)

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VF/2010/02

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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