Associations between enteral nutrition and outcomes in the SUP-ICU trial: Protocol for exploratory post hoc analyses.
enteral nutrition
pantoprazole
protocol
proton pump inhibitor
stress ulcer prophylaxis
Journal
Acta anaesthesiologica Scandinavica
ISSN: 1399-6576
Titre abrégé: Acta Anaesthesiol Scand
Pays: England
ID NLM: 0370270
Informations de publication
Date de publication:
04 2023
04 2023
Historique:
received:
19
12
2022
accepted:
01
01
2023
pubmed:
14
1
2023
medline:
24
3
2023
entrez:
13
1
2023
Statut:
ppublish
Résumé
Critically ill patients are at risk of gastrointestinal (GI) bleeding. Counter measures to minimise this risk include the use of pharmacological stress ulcer prophylaxis (SUP). The effect of enteral nutrition as SUP on GI bleeding event rates is unknown. There are conflicting data describing the effect of co-administration of enteral nutrition with pharmacological SUP, and there is substantial variation in practice. We aim to conduct an exploratory post hoc analysis to evaluate the association of enteral nutrition with clinically important GI bleed rates in ICU patients included in the SUP-ICU trial, and to explore any interactions between enteral nutrition and pharmacologic SUP on patient outcomes. The SUP-ICU trial dataset will be used to assess if enteral nutrition is associated with the outcomes of interest. Extended Cox models will be used considering relevant competing events, including treatment allocation (SUP or placebo) and enteral nutrition as a daily time-varying covariate, with additional adjustment for severity of illness (SAPS II). Results will be presented as adjusted hazard ratios for treatment allocation and enteral nutrition, and for treatment allocation and enteral nutrition considering potential interactions with the other variable, all with 95% confidence intervals and p-values for the tests of interaction. All results will be considered as exploratory only. This post hoc analysis may yield important insights to guide practice and inform the design of future randomised clinical trial investigating the effect of enteral nutrition on GI bleeding.
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
481-486Subventions
Organisme : Innovation Fund Denmark
ID : 4108-00011A
Organisme : Rigshospitalet
Organisme : Capital Region of Denmark
Organisme : Regions of Denmark
Organisme : Scandinavian Society of Anaesthesiology and Intensive Care Medicine
Organisme : Ehrenreich's Foundation
Organisme : Aase and Ejnar Danielsens Foundation
Organisme : Danish Society of Anaesthesiology and Intensive Care Medicine
Organisme : Danish Medical Association
Organisme : European Society of Intensive Care Medicine
Informations de copyright
© 2023 Acta Anaesthesiologica Scandinavica Foundation.
Références
Cook DJ, Griffith LE, Walter SD, et al. The attributable mortality and length of intensive care unit stay of clinically important gastrointestinal bleeding in critically ill patients. Crit Care. 2001;5:368-375.
Rhodes A, Evans LE, Alhazzani W, et al. Surviving sepsis campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017;45:486-552.
Pingleton S, Hadzima S. Enteral alimentation and gastrointestinal bleeding in mechanically ventilated patients. Crit Care Med. 1983;11:13-16.
Raff T, Germann G, Hartmann B. The value of early enteral nutrition in the prophylaxis of stress ulceration in the severely burned patient. Burns. 1997;23:313-318.
MacLaren R, Jarvis C, Fish D. Use of enteral nutrition for stress ulcer prophylaxis. Ann Pharmacother. 2001;35:35-1623. doi:10.1345/aph.1A083
Singer P, Reintam Blaser A, Berger MM, et al. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2018;38:48-79. doi:10.1016/j.clnu.2018.08.037
Reintam Blaser A, Starkopf J, Alhazzani W, et al. Early enteral nutrition in critically ill patients: ESICM clinical practice guidelines. Intensive Care Med. 2017;43:380-398.
Marik PE, Vasu T, Hirani A, Pachinburavan M. Stress ulcer prophylaxis in the new millennium: a systematic review and meta-analysis. Crit Care Med. 2010;38:2222-2228.
El-Kersh K, Jalil B, McClave SA, et al. Enteral nutrition as stress ulcer prophylaxis in critically ill patients: a randomized controlled exploratory study. J Crit Care. 2018;43:108-113.
Nourian A, Mohammadi M, Beigmohammadi M-T, et al. Comparing efficacy of enteral nutrition plus ranitidine and enteral nutrition alone as stress ulcer prophylaxis. J Comp Eff Res. 2018;7:493-501.
Huang H-B, Jiang W, Wang C-Y, Qin H-Y, Du B. Stress ulcer prophylaxis in intensive care unit patients receiving enteral nutrition: a systematic review and meta-analysis. Crit Care. 2018;22:20.
Reynolds PM, MacLaren R. Re-evaluating the utility of stress ulcer prophylaxis in the critically ill patient: a clinical scenario-based meta-analysis. Pharmacotherapy. 2019;39:408-420.
Granholm A, Zeng L, Dionne JC, et al. Predictors of gastrointestinal bleeding in adult ICU patients: a systematic review and meta-analysis. Intensive Care Med. 2019;45:1347-1359.
Ye Z, Reintam Blaser A, Lytvyn L, et al. Gastrointestinal bleeding prophylaxis for critically ill patients: a clinical practice guideline. BMJ. 2020;368:368. doi:10.1136/bmj.l6722
Krag M, Perner A, Wetterslev J, et al. Stress ulcer prophylaxis in the intensive care unit: an international survey of 97 units in 11 countries. Acta Anaesthesiol Scand. 2015;59:576-585.
Shears M, Alhazzani W, Marshall JC, et al. Stress ulcer prophylaxis in critical illness: a Canadian survey. Can J Anesth. 2016;63:718-724.
Jalil BA, El-Kersh K. Enteral nutrition better than proton pump inhibitors? Curr Opin Crit Care. 2019;25:334-339.
Krag M, Marker S, Perner A, et al. Pantoprazole in patients at risk for gastrointestinal bleeding in the ICU. N Engl J Med. 2018;379:2199-2208.
Krag M, Perner A, Wetterslev J, et al. Stress ulcer prophylaxis with a proton pump inhibitor versus placebo in critically ill patients (SUP-ICU trial): study protocol for a randomised controlled trial. Trials. 2016;17:205.
Krag M, Perner A, Wetterslev J, et al. Stress ulcer prophylaxis in the intensive care unit trial: detailed statistical analysis plan. Acta Anaesthesiol Scand. 2017;61:859-868.
Arabi YM, Aldawood AS, Haddad SH, et al. Permissive underfeeding or standard enteral feeding in critically ill adults. N Engl J Med. 2015;372:2398-2408.
Chapman M, Peake SL, Bellomo R, et al. TARGET I. energy-dense versus routine enteral nutrition in the critically ill. N Engl J Med. 2018;379:1823-1834.
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.
Beyersmann J, Allignol A, Schumacher M. Competing Risks and Multistate Models with R. Springer US; 2012.
Le Gall JR, Lemeshow S, Saulnier F. A new simplified acute physiology score (SAPS II) based on a European/north American multicenter study. JAMA. 1993;270:2957-2963.
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.
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.
Vesin A, Azoulay E, Ruckly S, et al. Reporting and handling missing values in clinical studies in intensive care units. Intensive Care Med. 2013;39:1396-1404.
van Buuren S, Groothuis-Oudshoorn K. Mice: multivariate imputation by chained equations in R. J Stat Softw. 2011;45:1-67. doi:10.18637/jss.v045.i03
Marshall A, Altman DG, Holder RL, Royston P. Combining estimates of interest in prognostic modelling studies after multiple imputation: current practice and guidelines. BMC Med Res Methodol. 2009;9:57.
Elm E v, Altman DG, Egger M, et al. Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007;335:806-808.
Krag M, Perner A, Wetterslev J, et al. Prevalence and outcome of gastrointestinal bleeding and use of acid suppressants in acutely ill adult intensive care patients. Intensive Care Med. 2015;41:833-845.
Heyland DK, Heyland RD, Cahill NE, et al. Creating a culture of clinical excellence in critical care nutrition: the 2008 “best of the best” award. J Parenter Enteral Nutr. 2010;34:707-715.
Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008;36:309-332.
Vincent J-L, Moreno R, Takala J, et al. The SOFA (sepsis-related organ failure assessment) score to describe organ dysfunction/failure. Intensive Care Med. 1996;22:707-710.