QT-prolongation in Psychiatric Hospitals

NCT02043925 — Completed, 152 participants, KU Leuven

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Registry	NCT02043925
Status	Completed
Study type	Observational
Enrollment	152 (Actual)
Sponsor	KU Leuven (Other); collaborators: Agentschap voor Innovatie door Wetenschap en Technologie
Conditions	QT-prolongation
Interventions	drugs linked with QT-prolongation (Drug)
Dates	start 2010-10-01, primary completion 2015-03-01, completion 2015-03-01, first posted 2014-01-23, last updated 2015-07-28
Locations	1 site in Belgium

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
psychiatric patients treated with QT-prolonging drugs		Drug: drugs linked with QT-prolongation

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

+Outcome measures

Primary outcomes

change in QTc-interval (corrected for heart rate) [before and one week after the start of a QT-prolonging drug]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Psychiatrisch Centrum Sint-Jan	Eeklo	Belgium

+Investigators

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

My Notes

Public

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