Protocol for a prospective cohort study on the use of clinical nutrition and assessment of long-term clinical and functional outcomes in critically ill adult patients

Abstract

Background and aims: Limited data are available on the impact of clinical nutrition over the course of critical illness and post-discharge outcomes. The present study aims to characterize the use of nutrition support in patients admitted to European intensive care units (ICUs), and its impact on clinical outcomes. Here we present the procedures of data collection and evaluation.

Methods: Around 100 medical, surgical, or trauma ICUs in 11 countries (Austria, Belgium, Czech Republic, Germany, France, Hungary, Italy, Poland, Spain, Sweden, United Kingdom) participate in the study. In defined months between November 2019 and April 2020, approximately 1250 patients are enrolled if staying in ICU for at least five consecutive days. Data from ICU day 1-4 are collected retrospectively, followed by a prospective observation period from day 5-90 after ICU admission. Data collection includes patient characteristics, nutrition parameters, complications, ICU and hospital length of stay, discharge status, and functional outcomes. For data analysis, the target is 1000 patients with complete data. Statistical analyses will be descriptive, with multivariate analyses adjusted for potential confounders to explore associations between nutritional balance and change in functional status, time-to-weaning from invasive mechanical ventilation, time to first clinical complication, and overall 15, 30 and 90-day survival.

Ethics and dissemination: This non-interventional study was reviewed and approved by the ethics committee of the Medical University Vienna, Vienna, Austria (approval number 1678/2019), and the respective ethical committees from participating sites at country and/or local level, as required. Results will be shared with investigators on a country level, and a publication and results presentation at the 2021 ESPEN Congress is planned.

Trial registration: ClinicalTrials.gov identifier NCT04143503.

Keywords: Clinical nutrition; Enteral; Functional status; ICU; Parenteral.

Conflict of interest statement

Declaration of competing interest M. Hiesmayr has received lecture fees and travel support from Fresenius Kabi, Nestlé, Baxter, SSPC, consulting fees from Fresenius from Fresenius Kabi, and unrestricted research grants from Baxter and Fresenius Kabi to Medical University Vienna. M. Matejovic has received lecture fees from Fresenius Kabi, Baxter, Nutricia and consulting fees and travel support from Fresenius Kabi. C. Vaquerizo has received lecture fees and travel support from Fresenius Kabi, Nestlé Healthcare Nutrition, Abbott Nutrition and Vegenat Nutrisens, and consulting fees from Fresenius Kabi and Vegenat Nutrisens. G. Elke has received lecture fees and travel support from Fresenius Kabi, Baxter and consulting fees and travel support from Cardinal Health, Fresenius Kabi and Nutricia. K. Dams has received lecture fees from Fresenius Kabi, Baxter, Nestlé and consulting fees and travel support from Fresenius Kabi. The rest of the authors have no conflicts of interest to declare in relation with this study.

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