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

NCT ID: NCT02043912

Last Updated: 2014-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-04-30

Brief Summary

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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 Description

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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.

Conditions

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QT-prolongation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients treated with haloperidol

Haloperidol

Intervention Type DRUG

Interventions

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Haloperidol

Intervention Type DRUG

Other Intervention Names

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Haldol

Eligibility Criteria

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Inclusion Criteria

* treatment with haloperidol (started in the hospital)

Exclusion Criteria

* age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agentschap voor Innovatie door Wetenschap en Technologie

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Eline Vandael

PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eline Vandael, PhD-student

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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Universitair Ziekenhuis Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EV002

Identifier Type: -

Identifier Source: org_study_id

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