Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital

NCT ID: NCT02068170

Last Updated: 2015-07-28

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

178 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-06-30

Brief Summary

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A prospective, observational study in a university hospital (UZ Leuven). Patients are included when they are treated with a potentional QT-prolonging drug: haloperidol for delirium, antibiotics (moxifloxacin, levofloxacin, azithromycin, clarithromycin, erythromycin, co-trimoxazole), antimycotics (ketoconazole, itraconazole, fluconazole, voriconazole), methadone, tacrolimus and oral oncolytics.

An ECG is taken before the administration of the drug and 3-5 days after starting the drug to investigate the change in duration of the QTc-interval. Risk factors for developing QT-prolongation will be documented. Together with ECG2, an additional blood sample will be collected to measure the blood concentration of the drug.

Detailed Description

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Conditions

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Delirium 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 a potentional QT-prolonging drug

Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib

Intervention Type DRUG

Interventions

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Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib

Intervention Type DRUG

Other Intervention Names

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haloperidol: Haldol, ATC-code: N05AD01 azithromycin: Zitromax, ATC-code: J01FA10 clarithromycin: Biclar, ATC-code: J01FA09 erythromycin: Erytroforte, ATC-code: J01FA01 levofloxacin: Tavanic, ATC-code: J01MA12 moxifloxacin: Avelox, ATC-code: J01MA14 co-trimoxazole: Bactrim, Eusaprim, ATC-code: J01EE01 voriconazole: Vfend, ATC-code: J02AC03 ketoconazole: Nizoral, ATC-code: J02AB02 fluconazole: Diflucan, ATC-code: J02AC01 itraconazole: Sporanox, ATC-code: J02AC02 methadone: ATC-code: N07BC02 tacrolimus: Prograft, Advagraft, ATC-code: L04AD02 sunitinib: Sutent, ATC-code: L01XE04

Eligibility Criteria

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Inclusion Criteria

* treatment with a potentional QT-prolonging drug of our list
* inpatient of UZ Leuven, admitted on one of the participating wards

Exclusion Criteria

* \< 18 years old
* DNR-code 3
* not possible to take an ECG before the start of haloperidol
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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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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Vandael E, Vandenberk B, Vandenberghe J, Spriet I, Willems R, Foulon V. Development of a risk score for QTc-prolongation: the RISQ-PATH study. Int J Clin Pharm. 2017 Apr;39(2):424-432. doi: 10.1007/s11096-017-0446-2. Epub 2017 Mar 9.

Reference Type DERIVED
PMID: 28281228 (View on PubMed)

Other Identifiers

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EV003

Identifier Type: -

Identifier Source: org_study_id

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