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

NCT02043912 — Completed, 222 participants, KU Leuven

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

Registry	NCT02043912
Status	Completed
Study type	Observational
Enrollment	222 (Actual)
Sponsor	KU Leuven (Other); collaborators: Agentschap voor Innovatie door Wetenschap en Technologie
Conditions	QT-prolongation
Interventions	Haloperidol (Drug)
Dates	start 2013-07-01, primary completion 2014-02-01, completion 2014-04-01, first posted 2014-01-23, last updated 2014-06-11
Locations	1 site in Belgium

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
patients treated with haloperidol		Drug: Haloperidol

Haloperidol (Drug), also known as Haldol

+Outcome measures

Primary outcomes

QTc-interval (corrected for heart rate) [maximum one year before inclusion / one week after inclusion]

Secondary outcomes

number of drug interactions (with risk of QT-prolongation) [one week before/after inclusion]

Other outcomes

number of patients with an ECG before or after the start of haloperidol [maximum one year before inclusion / one week after inclusion]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* treatment with haloperidol (started in the hospital)

Exclusion Criteria:

* age < 18 years

+Locations (1)

Facility	City	Country	Status
Universitair Ziekenhuis Leuven	Leuven	Belgium

+Investigators

Eline Vandael, PhD-student, Principal investigator, KU Leuven

My Notes

Public

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