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

Vera Crone; Morten Hylander Møller; Anders Granholm; Anders Perner; Waleed Alhazzani; Abdulrahman Al-Fares; Johanna Hästbacka; Marlies Ostermann; Carmen A Pfortmueller; Ricard Ferrer; Annika Reintam Blaser; Eric Keus; Wojciech Szczeklik; Mette Krag

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^*, Morten Hylander Møller, Anders Granholm, Anders Perner, Waleed Alhazzani, Abdulrahman Al-Fares, Johanna Hästbacka, Marlies Ostermann, Carmen A Pfortmueller, Ricard Ferrer, Annika Reintam Blaser, Eric Keus, Wojciech Szczeklik, Mette Krag

^*Corresponding author for this work

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.

Original language	English
Article number	e70125
Journal	Acta Anaesthesiologica Scandinavica
Volume	69
Issue number	9
Pages (from-to)	e70125
ISSN	0001-5172
DOIs	https://doi.org/10.1111/aas.70125
Publication status	Published - Oct 2025

Keywords

Humans
Intensive Care Units
Cohort Studies
Adult
Critical Care
Gastrointestinal Agents/adverse effects
Male
Female
Critical Illness

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Crone, V., Møller, M. H., Granholm, A., Perner, A., Alhazzani, W., Al-Fares, A., Hästbacka, J., Ostermann, M., Pfortmueller, C. A., Ferrer, R., Reintam Blaser, A., Keus, E., Szczeklik, W., & Krag, M. (2025). Selected Serious Adverse Events in a Cohort of Adult ICU Patients: Protocol for a Sub-Study of the PATIENCE Cohort. Acta Anaesthesiologica Scandinavica, 69(9), e70125. Article e70125. https://doi.org/10.1111/aas.70125

Crone, V, Møller, MH , Granholm, A , Perner, A, Alhazzani, W, Al-Fares, A, Hästbacka, J, Ostermann, M, Pfortmueller, CA, Ferrer, R, Reintam Blaser, A, Keus, E, Szczeklik, W & Krag, M 2025, 'Selected Serious Adverse Events in a Cohort of Adult ICU Patients: Protocol for a Sub-Study of the PATIENCE Cohort', Acta Anaesthesiologica Scandinavica, vol. 69, no. 9, e70125, pp. e70125. https://doi.org/10.1111/aas.70125

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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.",

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T1 - Selected Serious Adverse Events in a Cohort of Adult ICU Patients

T2 - Protocol for a Sub-Study of the PATIENCE Cohort

AU - Crone, Vera

AU - Møller, Morten Hylander

AU - Granholm, Anders

AU - Perner, Anders

AU - Alhazzani, Waleed

AU - Al-Fares, Abdulrahman

AU - Hästbacka, Johanna

AU - Ostermann, Marlies

AU - Pfortmueller, Carmen A

AU - Ferrer, Ricard

AU - Reintam Blaser, Annika

AU - Keus, Eric

AU - Szczeklik, Wojciech

AU - Krag, Mette

PY - 2025/10

Y1 - 2025/10

N2 - 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.

AB - 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.

KW - Humans

KW - Intensive Care Units

KW - Cohort Studies

KW - Adult

KW - Critical Care

KW - Gastrointestinal Agents/adverse effects

KW - Male

KW - Female

KW - Critical Illness

UR - https://www.scopus.com/pages/publications/105016659883

U2 - 10.1111/aas.70125

DO - 10.1111/aas.70125

M3 - Journal article

C2 - 40965428

SN - 0001-5172

VL - 69

SP - e70125

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

IS - 9

M1 - e70125

ER -

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

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Keywords

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