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Hartritmestoornissen (QT-verlenging op het ECG) door domperidon

QT-prolongation by domperidone: frequency and associated characteristics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28199
Enrollment
300
Registered
2014-04-15
Start date
2014-09-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

QT-prolongation, cardiac dysrythmias

Interventions

None. It concerns an observational study. Domperidone is prescribed as part of usual care.

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - new prescription of domperidone while hospitalised in the Erasmus Medical Center - age 18 years and older

Exclusion criteria

Exclusion criteria: - no informed consent - terminally ill patient - incompetent patient - congenital prolonged QT-syndrome

Design outcomes

Primary

MeasureTime frame
QT-time on ECG performed 30-60 minutes after the fourth dosage of domperidone.

Secondary

MeasureTime frame
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.

Contacts

Public ContactP.M.L.A. Bemt, van den

Erasmus MC Hospital Pharmacy P.O. Box 2040

p.vandenbemt@erasmusmc.nl+31 10 7033202

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)