Sistema de Salut de Catalunya
Institut Català de la Salut
[Crone V] Department of Intensive Care, Holbæk Hospital, Holbæk, Denmark. [Møller MH, Perner A] Department of Intensive Care, Copenhagen University Hospital – Rigshospitalet, Copenhagen, Denmark. Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. [Granholm A] Department of Intensive Care, Copenhagen University Hospital – Rigshospitalet, Copenhagen, Denmark. Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark. [Alhazzani W] Scientific Research Centre, Ministry of Defence Health Services, Riyadh, Saudi Arabi. Department of Critical Care Medicine, King Saud University, Riyadh, Saudi Arabia. [Al-Fares A] Department of Anaesthesia, Critical Care Medicine and Pain Medicine, Al-Amiri Hospital, Ministry of Health, Kuwait City, Kuwait. [Ferrer R] Vall d’Hebron Hospital Universitari, Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
2025-12-15T13:21:15Z
2025-12-15T13:21:15Z
2025-10
Adverse events; Adult patients; ICU
Esdeveniments adversos; Pacients adults; UCI
Eventos adversos; Pacientes adultos; UCI
Background Serious adverse events (SAEs) are a relevant patient safety concern in critically ill patients, yet epidemiological data on their occurrence in the intensive care unit (ICU) remain limited. This sub-study of the PATIENCE cohort study aims to describe the occurrence of selected SAEs in adult ICU patients with and without prokinetic treatment. Methods This is a protocol and statistical analysis plan for a post hoc sub-study of the “Prokinetic agents in adult intensive care unit patients—An international inception cohort study (PATIENCE)” which has included 1440 acutely admitted adult ICU patients from 11 countries. The primary outcome is the proportion of patients experiencing selected SAEs, assessed according to exposure to prokinetic treatment. Secondary outcomes include the proportion of patients experiencing each specific SAE, their distribution by treatment duration, and timing in relation to ICU admission and prokinetic use. Furthermore, patient characteristics for those with and without the SAEs will be described. Data will be presented descriptively. Conclusion This sub-study will use data from the international PATIENCE cohort study to provide epidemiological data on the occurrence of SAEs potentially related to prokinetic use in adult ICU patients.
Article
Versió publicada
Anglès
Medicaments gastrointestinals - Ús terapèutic - Efectes secundaris; Unitats de cures intensives; Malalts en estat crític; HEALTH CARE::Health Care Facilities, Manpower, and Services::Health Facilities::Hospital Units::Intensive Care Units; DISEASES::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Critical Illness; CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Gastrointestinal Agents; Other subheadings::Other subheadings::Other subheadings::/adverse effects; ATENCIÓN DE SALUD::instalaciones, servicios y personal de asistencia sanitaria::centros sanitarios::unidades hospitalarias::unidades de cuidados intensivos; ENFERMEDADES::afecciones patológicas, signos y síntomas::procesos patológicos::atributos de la enfermedad::enfermedad crítica; COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::fármacos gastrointestinales; Otros calificadores::Otros calificadores::Otros calificadores::/efectos adversos
Wiley
Acta Anaesthesiologica Scandinavica;69(9)
https://doi.org/10.1111/aas.70125
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
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