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…
ID
Bron
Verkorte titel
Aandoening
QT-prolongation, cardiac dysrythmias
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
QT-time on ECG performed 30-60 minutes after the fourth dosage of domperidone.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
1-2 days after starting domperidone.
Onderzoeksproduct en/of interventie
None. It concerns an observational study.
Domperidone is prescribed as part of usual care.
Algemeen / deelnemers
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
Wetenschappers
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- new prescription of domperidone while hospitalised in the Erasmus Medical Center
- age 18 years and older
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- no informed consent
- terminally ill patient
- incompetent patient
- congenital prolonged QT-syndrome
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