Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Oct;69(9):e70125.
doi: 10.1111/aas.70125.

Selected Serious Adverse Events in a Cohort of Adult ICU Patients: Protocol for a Sub-Study of the PATIENCE Cohort

Vera Crone  1 , Morten Hylander Møller  2   3 , Anders Granholm  2   4 , Anders Perner  2   3 , Waleed Alhazzani  5   6 , Abdulrahman Al-Fares  7 , Johanna Hästbacka  8 , Marlies Ostermann  9 , Carmen A Pfortmueller  10 , Ricard Ferrer  11 , Annika Reintam Blaser  12   13 , Eric Keus  14 , Wojciech Szczeklik  15 , Mette Krag  3   16
Affiliations

Selected Serious Adverse Events in a Cohort of Adult ICU Patients: Protocol for a Sub-Study of the PATIENCE Cohort

Vera Crone et al. Acta Anaesthesiol Scand. 2025 Oct.

Abstract

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.

PubMed Disclaimer

Conflict of interest statement

The Department of Intensive Care at Rigshospitalet—Copenhagen University Hospital (M.H.M., A.G., A.P.) has received funding from the Independent Research Fund Denmark, Novo Nordisk Foundation, and Sygeforsikringen “danmark” outside the submitted work. A.R.B. has received speaker or consultancy fees from Nutricia and VIPUN Medical and is holding a grant from the Estonian Research Council (PRG1255). J.H. has received reimbursement for advisory board work (Paion) outside the submitted work. Ricard Ferrer has received honoraria from Shionogi, MSD, Gilead, Menarini, Thermofisher, Viatris and AOP outside the submitted work.

References

    1. Safety Reporting During Clinical Medicinal Trials, https://laegemiddelstyrelsen.dk/en/licensing/clinical‐trials/safety‐repo....
    1. Jensen M. Q., Munch M. W., Granholm A., Møller M. H., Bahrenkova M., and Perner A., “Serious Adverse Events Reporting in Recent Randomised Clinical Trials in Intensive Care Medicine—A Methodological Study Protocol,” Acta Anaesthesiologica Scandinavica 68 (2024): 1581–1587. - PubMed
    1. Lewis K., Alqahtani Z., Mcintyre L., et al., “The Efficacy and Safety of Prokinetic Agents in Critically Ill Patients Receiving Enteral Nutrition: A Systematic Review and Meta‐Analysis of Randomized Trials,” Critical Care 20 (2016): 259. - PMC - PubMed
    1. Nguyen N. Q., Chapman M., Fraser R. J., Bryant L. K., Burgstad C., and Holloway R. H., “Prokinetic Therapy for Feed Intolerance in Critical Illness: One Drug or Two?,” Critical Care Medicine 35 (2007): 2561–2567. - PubMed
    1. Rao A. S. and Camilleri M., “Review Article: Metoclopramide and Tardive Dyskinesia,” Alimentary Pharmacology & Therapeutics 31 (2010): 11–19. - PubMed

Substances

LinkOut - more resources