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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02068170
Acronym
RISQ-PATH
Enrollment
178
Registered
2014-02-21
Start date
2014-02-28
Completion date
2015-06-30
Last updated
2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, QT-prolongation

Keywords

QT-prolongation, Torsade de Pointes, QT-prolonging drugs

Brief 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.

Interventions

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

Sponsors

Agentschap voor Innovatie door Wetenschap en Technologie
CollaboratorOTHER
KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
change in QTc-interval (corrected for heart rate)before and 3-5 days after the start of a potentional QT-prolonging drug

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026