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NCT02068170 Clinical Trial

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

Delirium Clinical Trial

— RISQ-PATH  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02068170
Other study ID # EV003
Secondary ID
Status Completed
Phase N/A
First received February 18, 2014
Last updated July 27, 2015
Start date February 2014
Est. completion date June 2015

Study information
Verified date July 2015
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date June 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium UZ 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
Primary change in QTc-interval (corrected for heart rate) before and 3-5 days after the start of a potentional QT-prolonging drug Yes
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