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

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.