Serious Adverse Events in Adult ICU Patients: A Substudy of the PATIENCE Cohort.
16 affiliations
- 1Department of Intensive Care, Holbæk Hospital, Holbæk, Denmark.
- 2Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
- 3Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
- 4Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
- 5Research and Innovation Institute, Ministry of Defense Health Services, Riyadh, Saudi Arabia.
- 6Critical Care and Internal Medicine Department, College of Medicine, Imam Abdulrahman Bin Faisal University, Riyadh, Saudi Arabia.
- 7Department of Anaesthesia, Critical Care Medicine and Pain Medicine, Al-Amiri Hospital, Ministry of Health, Kuwait City, Kuwait.
- 8Department of Intensive Care, Tampere University Hospital, Wellbeing Services County of Pirkanmaa and Tampere University, Tampere, Finland.
- 9Department of Critical Care, King's College London, Guy's and St. Thomas' Hospital, London, UK.
- 10Department of Intensive Care, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
- 11Department of Intensive Care, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
- 12Department of Anaesthesiology and Intensive Care, University of Tartu, Tartu, Estonia.
- 13Department of Intensive Care Medicine, Lucerne Cantonal Hospital, Lucerne, Switzerland.
- 14Department of Critical Care, University Medical Center Groningen, Groningen, the Netherlands.
- 15Center for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Krakow, Poland.
- 16Department of Anaesthesiology, Surgery and Trauma Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Abstract
Introduction
Prokinetic agents are used to enhance upper gastrointestinal motility, but adverse events related to these agents are poorly described. We aimed to provide detailed epidemiological data on predefined serious adverse events (SAEs) in a cohort of adult intensive care unit (ICU) patients with and without prokinetic treatment. We hypothesised that all predefined SAEs would occur in both patients treated and those not treated with prokinetic agents, and that a higher number of SAEs would occur among patients treated with prokinetic agents for more than three consecutive days.Methods
This substudy of the inception cohort study "Prokinetic agents in adult intensive care unit patients" included acutely admitted adult ICU patients. The prokinetic agents assessed (exposures) were erythromycin, metoclopramide, domperidone, and prucalopride. The primary outcome was the proportion of patients experiencing at least one episode of five pre-specified SAEs during ICU stay (cardiac arrhythmias, cardiac arrest, vomiting with aspiration, diarrhoea, extrapyramidal symptoms). Secondary outcomes were (1) proportion of patients experiencing each SAE, (2) the proportion of patients experiencing any of the SAEs after prokinetic treatment stratified by longest consecutive treatment duration, (3) time from index ICU admission to first SAE and (4) time from prokinetic initiation to first SAE. All analyses were descriptive, summarising SAE proportions and timing overall and according to prokinetic exposure.Results
Among 1440 adult ICU patients, 710 SAEs occurred in 354 patients (24.6%), most commonly cardiac arrhythmias (199/1440, 13.8%). Across the exposure groups, the proportion of patients experiencing one or more SAEs ranged from 23.0% to 42.5%. Among patients treated with prokinetic agents for > 3 consecutive days, 14/59 (23.7%) experienced a SAE, which was similar to the proportion observed among patients not receiving prokinetic agents (291/1.253, 23.2%). Most SAEs occurred on median Day 2 after ICU admission and on median Day 3 after prokinetic initiation.Conclusion
One in four adult ICU patients experienced at least one SAE, with cardiac arrhythmias being the most frequent. Among patients receiving prokinetic agents, the proportion experiencing one or more SAEs ranged from 23.0% to 42.5% across treatment groups. The findings from this study may help inform the design of a future clinical trial.Editorial comment
This analysis presents reported serious adverse event observed in an ICU trial cohort assessing gastrointestinal prokinetic drug effects. Serious adverse events were reported frequently in both the drug treatment groups and the comparison (no prokinetic drug) group. Types of serious adverse events reported are presented.
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BibTeX
@article{crone2026serious,
title = {{Serious Adverse Events in Adult ICU Patients: A Substudy of the PATIENCE Cohort.}},
author = {Vera Crone and Morten Hylander Møller and Anders Granholm and Anders Perner and Waleed Alhazzani and Abdulrahman Al-Fares and Johanna Hästbacka and Marlies Ostermann and Carmen A Pfortmueller and Ricard Ferrer and Annika Reintam Blaser and Eric Keus and Wojciech Szczeklik and Mette Krag},
journal = {Acta anaesthesiologica Scandinavica},
year = {2026},
month = oct,
doi = {10.1111/aas.70382},
url = {https://europepmc.org/article/MED/42963077},
note = {CC BY},
}
RIS
TY - JOUR
TI - Serious Adverse Events in Adult ICU Patients: A Substudy of the PATIENCE Cohort.
AU - Vera Crone
AU - Morten Hylander Møller
AU - Anders Granholm
AU - Anders Perner
AU - Waleed Alhazzani
AU - Abdulrahman Al-Fares
AU - Johanna Hästbacka
AU - Marlies Ostermann
AU - Carmen A Pfortmueller
AU - Ricard Ferrer
AU - Annika Reintam Blaser
AU - Eric Keus
AU - Wojciech Szczeklik
AU - Mette Krag
PY - 2026
DA - 2026/10/30
JO - Acta anaesthesiologica Scandinavica
DO - 10.1111/aas.70382
UR - https://europepmc.org/article/MED/42963077
AB - Introduction Prokinetic agents are used to enhance upper gastrointestinal motility, but adverse events related to these agents are poorly described. We aimed to provide detailed epidemiological data on predefined serious adverse events (SAEs) in a cohort of adult intensive care unit (ICU) patients with and without prokinetic treatment. We hypothesised that all predefined SAEs would occur in both patients treated and those not treated with prokinetic agents, and that a higher number of SAEs would occur among patients treated with prokinetic agents for more than three consecutive days.Methods This substudy of the inception cohort study "Prokinetic agents in adult intensive care unit patients" included acutely admitted adult ICU patients. The prokinetic agents assessed (exposures) were erythromycin, metoclopramide, domperidone, and prucalopride. The primary outcome was the proportion of patients experiencing at least one episode of five pre-specified SAEs during ICU stay (cardiac arrhythmias, cardiac arrest, vomiting with aspiration, diarrhoea, extrapyramidal symptoms). Secondary outcomes were (1) proportion of patients experiencing each SAE, (2) the proportion of patients experiencing any of the SAEs after prokinetic treatment stratified by longest consecutive treatment duration, (3) time from index ICU admission to first SAE and (4) time from prokinetic initiation to first SAE. All analyses were descriptive, summarising SAE proportions and timing overall and according to prokinetic exposure.Results Among 1440 adult ICU patients, 710 SAEs occurred in 354 patients (24.6%), most commonly cardiac arrhythmias (199/1440, 13.8%). Across the exposure groups, the proportion of patients experiencing one or more SAEs ranged from 23.0% to 42.5%. Among patients treated with prokinetic agents for > 3 consecutive days, 14/59 (23.7%) experienced a SAE, which was similar to the proportion observed among patients not receiving prokinetic agents (291/1.253, 23.2%). Most SAEs occurred on median Day 2 after ICU admission and on median Day 3 after prokinetic initiation.Conclusion One in four adult ICU patients experienced at least one SAE, with cardiac arrhythmias being the most frequent. Among patients receiving prokinetic agents, the proportion experiencing one or more SAEs ranged from 23.0% to 42.5% across treatment groups. The findings from this study may help inform the design of a future clinical trial.Editorial comment This analysis presents reported serious adverse event observed in an ICU trial cohort assessing gastrointestinal prokinetic drug effects. Serious adverse events were reported frequently in both the drug treatment groups and the comparison (no prokinetic drug) group. Types of serious adverse events reported are presented.
SN - 0001-5172
SN - 1399-6576
ER -