Prokinetic agents in adult intensive care unit patients (PATIENCE)-An international inception cohort study protocol.
cohort study
intensive care
prokinetic agents
protocol
Journal
Acta anaesthesiologica Scandinavica
ISSN: 1399-6576
Titre abrégé: Acta Anaesthesiol Scand
Pays: England
ID NLM: 0370270
Informations de publication
Date de publication:
30 Sep 2024
30 Sep 2024
Historique:
received:
04
09
2024
accepted:
19
09
2024
medline:
1
10
2024
pubmed:
1
10
2024
entrez:
1
10
2024
Statut:
aheadofprint
Résumé
Feeding intolerance is common in critically ill patients and can lead to malnutrition. Prokinetic agents may be used to enhance the uptake of nutrition. However, the evidence on the effectiveness and safety of prokinetic agents is sparse, and there is a lack of data on their use in intensive care units (ICU). We will conduct an international 14-day inception cohort study of 1000 acutely admitted adult ICU patients. Data will be collected from ICU admission and daily during ICU stay for up to 90 days. The primary outcome will be the proportion of ICU patients who receive prokinetic agents. Secondary outcomes include mortality, days alive without life support, days alive out of ICU, days alive out of hospital (all within 90 days) and the number of patients with one or more serious adverse events. We will present data on the use of prokinetic agents descriptively and use Cox regressions with death and ICU discharge as competing events to evaluate the association between patient characteristics and the use of prokinetic agents. We will use extended Cox models with time-varying covariates and linear regression models to assess the associations between the use of prokinetic agents and the secondary outcomes. The outlined international cohort study will provide valuable epidemiological data on the use of prokinetic agents in adult, acutely admitted ICU patients.
Sections du résumé
BACKGROUND
BACKGROUND
Feeding intolerance is common in critically ill patients and can lead to malnutrition. Prokinetic agents may be used to enhance the uptake of nutrition. However, the evidence on the effectiveness and safety of prokinetic agents is sparse, and there is a lack of data on their use in intensive care units (ICU).
METHODS
METHODS
We will conduct an international 14-day inception cohort study of 1000 acutely admitted adult ICU patients. Data will be collected from ICU admission and daily during ICU stay for up to 90 days. The primary outcome will be the proportion of ICU patients who receive prokinetic agents. Secondary outcomes include mortality, days alive without life support, days alive out of ICU, days alive out of hospital (all within 90 days) and the number of patients with one or more serious adverse events.
RESULTS
RESULTS
We will present data on the use of prokinetic agents descriptively and use Cox regressions with death and ICU discharge as competing events to evaluate the association between patient characteristics and the use of prokinetic agents. We will use extended Cox models with time-varying covariates and linear regression models to assess the associations between the use of prokinetic agents and the secondary outcomes.
CONCLUSION
CONCLUSIONS
The outlined international cohort study will provide valuable epidemiological data on the use of prokinetic agents in adult, acutely admitted ICU patients.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.
Références
Doherty WL, Winter B. Prokinetic agents in critical care. Crit Care. 2003;7:206‐208.
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 randomised trials. Crit Care. 2016;20(1):259.
Singer P, Blaser AR, Berger MM, et al. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019;38:48‐79.
McClave SA, Taylor BE, Martindale RG, et al. Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). J Parenter Enteral Nutr. 2016;40:159‐211.
Crone V, Møller MH, Bækgaard ES, et al. Use of prokinetic agents in hospitalised adult patients: a scoping review. Acta Anaesthesiol Scand. 2023;67:588‐598.
Vandenbroucke JP, von Elm E, Altman DG, et al. Strengthening the reporting of observational studies in epidemiology (STROBE): explanation and elaboration. Int J Surg. 2014;12:1500‐1524.
REDCap. https://redcap.regionsjaelland.dk/index.php?action=passwordreset&u=c2pfY3JvdmVy&k=14dd0645cfdee674d5edc46af6affc1de29f52207c157cd3fb50e2b673ba6c60726fef291c70c88c3dc0e9323e93a6b0f3fd849af19fbe40163e7d23db63682e.
Granholm A, Perner A, Jensen AKG, Møller MH. Development and internal validation of the Simplified Mortality Score for the Intensive Care Unit (SMS‐ICU). Acta Anaesthesiol Scand. 2018;62:409‐410.
Heyland DK, Ortiz A, Stoppe C, et al. Incidence, risk factors, and clinical consequence of enteral feeding intolerance in the mechanically ventilated critically ill: an analysis of a multicenter, multiyear database. Crit Care Med. 2020;49:49‐59.
Reintam Blaser A, Deane AM, Preiser JC, Arabi YM, Jakob SM. Enteral feeding intolerance: updates in definitions and pathophysiology. Nutr Clin Pract. 2021;36:40‐49.
Schmoor C, Schumacher M, Finke J, Beyersmann J. Competing risks and multistate models. Clin Cancer Res. 2013;19:12‐21.
Clark TG, Bradburn MJ, Love SB, Altman DG. Survival analysis part IV: further concepts and methods in survival analysis. Br J Cancer. 2003;89:781‐786.
Bradburn MJ, Clark TG, Love SB, Altman DG. Survival analysis part III: multivariate data analysis – choosing a model and assessing its adequacy and fit. Br J Cancer. 2003;89:605‐611.
Granholm A, Anthon CT, Kjær MBN, et al. Patient‐important outcomes other than mortality in contemporary ICU trials: a scoping review. Crit Care Med. 2022;50:E759‐E771.
Auriemma CL, Taylor SP, Harhay MO, Courtright KR, Halpern SD. Hospital‐free days: a pragmatic and patient‐centered outcome for trials among critically and seriously ill patients. Am J Respir Crit Care Med. 2021;204:902‐909.
Granholm A, Kaas‐Hansen BS, Lange T, et al. Use of days alive without life support and similar count outcomes in randomised clinical trials – an overview and comparison of methodological choices and analysis methods. BMC Med Res Methodol. 2023;23:139.
Bland JM, Altman DG. Statistics notes: bootstrap resampling methods. BMJ (Online). 2015;350:h2622.
Rafi Z, Greenland S. Semantic and cognitive tools to aid statistical science: replace confidence and significance by compatibility and surprise. BMC Med Res Methodol. 2020;20:244.
Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts. BMC Med Res Methodol. 2017;17:162.
Sterne JAC, White IR, Carlin JB, et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ (Online). 2009;338:b2393.
ICMJE | Recommendations | Defining the Role of Authors and Contributors. https://www.icmje.org/recommendations/browse/roles‐and‐responsibilities/defining‐the‐role‐of‐authors‐and‐contributors.html.
Singer P, Blaser AR, Berger MM, et al. ESPEN practical and partially revised guideline: clinical nutrition in the intensive care unit. Clin Nutr. 2023;42:1671‐1689.
Hess AS, Abd‐Elsayed A. Observational studies: uses and limitations. Pain. Springer International Publishing; 2019:123‐125.