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. (June 2021)

• Record Type: Journal Article
• Authors: Hiesmayr, M.; Csomos, A.; Dams, K.; Elke, G.; Hartl, W.; Huet, O.; Krzych, L.J.; Kuechenhoff, H.; Matejovic, M.; Puthucheary, Z.A.; Rooyackers, O.; Tetamo, R.; Tjäder, I.; Vaquerizo, C.
• Is Part Of: Clinical nutrition ESPEN. Volume 43(2021)
• Page Start: 104
• Page End: 110
• Publication Date: 2021-06
• Subjects: ICU -- Clinical nutrition -- Functional status -- Parenteral -- Enteral; Nutritionally induced diseases -- Periodicals; Metabolism -- Disorders -- Periodicals; 616.39005
• DOI: 10.1016/j.clnesp.2021.01.048
• Languages: English
• ISSNs: 2405-4577

Abstract

Summary: 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. Highlights: The largest real-world data collection on clinical nutrition in European critically ill patients staying in the ICU ≥5 days. Results include functional outcomes and evidence concerning optimal amounts and timing of nutrition support. Hidden substrates from drugs, renal replacement therapy, oral nutrition and supplements are included in substrate balance. Exploratory analyses between potential predictors and functional outcomes might be affected by patients lost to follow-up. Limitations may arise from selection and information bias as well as confounding from informative missing of data.