DeliriumRISQ-PATHNCT02068170
Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital
An observational study of Delirium and QT-prolongation, run by KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, QT-prolongation
- What is being tested?
- Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib
- How many people
- 178 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with acute potentional QT-prolonging medication. In a university hospital.
Who may be able to join
- treatment with a potentional QT-prolonging drug of our list
- inpatient of UZ Leuven, admitted on one of the participating wards
Who cannot join
- < 18 years old
- DNR-code 3
- not possible to take an ECG before the start of haloperidol
Trial locations and contacts
1 site in 1 country.
About this study
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
- Delirium, QT-prolongation
- Being tested
- Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib
- Keywords
- QT-prolongation, Torsade de Pointes, QT-prolonging drugs
- Medical subject headings
- Delirium, Long QT Syndrome, Torsades de Pointes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinibDrug
Also called haloperidol: Haldol, ATC-code: N05AD01, azithromycin: Zitromax, ATC-code: J01FA10, clarithromycin: Biclar, ATC-code: J01FA09, erythromycin: Erytroforte, ATC-code: J01FA01
| Study group | Role | What they receive |
|---|---|---|
| patients treated with a potentional QT-prolonging drug | Not described Receives: Drug: Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in QTc-interval (corrected for heart rate)
Measured: before and 3-5 days after the start of a potentional QT-prolonging drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Responsible party
- Principal investigator, Eline Vandael, KU Leuven
- Investigators
- Eline Vandael, PhD-student, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068170
- Sponsor's protocol ID
- EV003
- Acronym
- RISQ-PATH
- Status last verified
- Jul 2015
- First submitted
- 18 Feb 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28281228
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital
- ClinicalTrials.gov ID
- NCT02068170
- Acronym / sponsor ID
- RISQ-PATH / EV003
- Conditions
- Delirium, QT-prolongation
- Keywords
- QT-prolongation, Torsade de Pointes, QT-prolonging drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients treated with a potentional QT-prolonging drug | – | Drug: Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with acute potentional QT-prolonging medication. In a university hospital.
Key inclusion criteria (2 listed)
- treatment with a potentional QT-prolonging drug of our list
- inpatient of UZ Leuven, admitted on one of the participating wards
Key exclusion criteria (3 listed)
- < 18 years old
- DNR-code 3
- not possible to take an ECG before the start of haloperidol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinibAlso: haloperidol: Haldol, ATC-code: N05AD01, azithromycin: Zitromax, ATC-code: J01FA10, clarithromycin: Biclar, ATC-code: J01FA09, erythromycin: Erytroforte, ATC-code: J01FA01 | Drug | patients treated with a potentional QT-prolonging drug |
Primary outcome
change in QTc-interval (corrected for heart rate)
Time frame: before and 3-5 days after the start of a potentional QT-prolonging drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- Derived from this study: PubMed 28281228Vandael 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eline Vandael, PhD-student principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and QT-prolongation, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in QTc-interval (corrected for heart rate) (time frame: before and 3-5 days after the start of a potentional QT-prolonging drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02068170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.