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

QT-prolongation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043912
• Other study ID #: EV002
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: June 10, 2014
• Start date: July 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• treatment with haloperidol (started in the hospital)

Exclusion Criteria:

• age < 18 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Long QT Syndrome
• QT-prolongation

Intervention

Drug:
• Haloperidol

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Agentschap voor Innovatie door Wetenschap en Technologie

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of patients with an ECG before or after the start of haloperidol		maximum one year before inclusion / one week after inclusion	Yes
Primary	QTc-interval (corrected for heart rate)		maximum one year before inclusion / one week after inclusion	Yes
Secondary	number of drug interactions (with risk of QT-prolongation)		one week before/after inclusion	Yes