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Hartritmestoornissen (QT-verlenging op het ECG) door domperidon


- candidate number17493
- NTR NumberNTR4515
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-apr-2014
- Secondary IDsNL49083.078.14 (ABR) 2014-001769-29 (EUDRACT)
- Public TitleHartritmestoornissen (QT-verlenging op het ECG) door domperidon
- Scientific TitleQT-prolongation by domperidone: frequency and associated characteristics
- ACRONYMQT-DOM
- hypothesisIn 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.
- Healt Condition(s) or Problem(s) studiedHearth rhythm disorders, QT-prolongation
- 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2014
- planned closingdate1-sep-2015
- Target number of participants300
- InterventionsNone. It concerns an observational study. Domperidone is prescribed as part of usual care.
- Primary outcomeQT-time on ECG performed 30-60 minutes after the fourth dosage of domperidone.
- Secondary outcomeQT-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.
- Timepoints1-2 days after starting domperidone.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. P.M.L.A. Bemt, van den
- CONTACT for SCIENTIFIC QUERIESDr. P.M.L.A. Bemt, van den
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsNone.
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD15-apr-2014 - 8-mei-2014


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