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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Katholieke Universiteit Leuven

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

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Katholieke Universiteit Leuven

Dates:
Date Received: January 21, 2014
Date Started: July 2013
Date Completion:
Last Updated: June 10, 2014
Last Verified: June 2014