No registrations found.
ID
Source
Brief title
Health condition
QT-prolongation, cardiac dysrythmias
Sponsors and support
Intervention
Outcome measures
Primary outcome
QT-time on ECG performed 30-60 minutes after the fourth dosage of domperidone.
Secondary outcome
QT-time on 24 hour (continuous) ECG
Several characteristics will be collected in order to establish the potential association of these characteristics with the primary outcome:
- serum concentration of domperidone 30-60 minutes after the fourth dosage of domperidone
- pharmacogenetics (CYP3A4, CYP1A2, CYP2E1)
- general patient characteristics (age, gender, body weight, comorbidities, renal and hepatic function, serum electrolyte parameters)
- domperidone dosage
- comedication.
Background summary
In literature, domperidone has been linked to QT-prolongation resulting in acute cardial dysrythmias and sudden death. However, in practice doctors are still in need of domperidone. We hypothesize that in normal dosages QT-prolongation is relatively infrequent and we expect we can identify clear risk factors that may guide doctors in safe prescribing of domperidone. In order to test this hypothesis, an observational study will be designed. All patients aged 18 years and older who start with domperidone while hospitalised in the Erasmus MC will be included. Excluded are patients who do not give informed consent, who are incompetent and who suffer from the congenital prolonged QT-syndrome.
Primary outcome will be QT time on the ECG, performed 30-60 minutes after the fourth dosage of domperidone. Secondary outcome will be a continuous QT-time measurement during 24 hours, starting after the fourth dosage.
We will look into the following potential risk factors:
- serum concentration of domperidone 30-60 minutes after the fourth dosage of domperidone
- pharmacogenetics (CYP3A4, CYP1A2, CYP2E1)
- general patient characteristics (age, gender, body weight, comorbidities, renal and hepatic function, serum electrolyte parameters)
- domperidone dosage
- comedication.
We expect to include 300 patients in one year.
Study objective
In literature, domperidone has been linked to QT-prolongation resulting in acute cardial dysrythmias and sudden death. However, in practice doctors are still in need of domperidone. We hypothesize that in normal dosages QT-prolongation is relatively infrequent and we expect we can identify clear risk factors that may guide doctors in safe prescribing of domperidone.
Study design
1-2 days after starting domperidone.
Intervention
None. It concerns an observational study.
Domperidone is prescribed as part of usual care.
Hospital Pharmacy
P.O. Box 2040
P.M.L.A. Bemt, van den
Rotterdam 3000 CA
The Netherlands
+31 10 7033202
p.vandenbemt@erasmusmc.nl
Hospital Pharmacy
P.O. Box 2040
P.M.L.A. Bemt, van den
Rotterdam 3000 CA
The Netherlands
+31 10 7033202
p.vandenbemt@erasmusmc.nl
Inclusion criteria
- new prescription of domperidone while hospitalised in the Erasmus Medical Center
- age 18 years and older
Exclusion criteria
- no informed consent
- terminally ill patient
- incompetent patient
- congenital prolonged QT-syndrome
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4384 |
NTR-old | NTR4515 |
CCMO | NL49083.078.14 |
OMON | NL-OMON40915 |