Trials / Completed
CompletedNCT02068170
Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 178 (actual)
- Sponsor
- KU Leuven · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2015-03-01
- Completion
- 2015-06-01
- First posted
- 2014-02-21
- Last updated
- 2015-07-28
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02068170. Inclusion in this directory is not an endorsement.