ASPEN Joins Dr. Daren Heyland in EFFORT Trial

A burning question in today’s clinical practice with critically ill patients is how much protein is required to optimize patient outcomes. Our recent clinical guidelines for critical illness in adults recommend protein doses of 1.2-2.0 g/kg body weight daily.1 Large observational studies generally support lower mortality with greater protein intake.7,8  The existing randomized clinical trials on this subject have tested varied doses of protein intake,2-6 have small sample sizes and thus lack statistical power. These studies suggest no significant mortality reduction with greater protein intake. Indeed, post hoc analyses of randomized trials suggest that more protein may be associated with harm. 9-11 Hence, there is confusion about the most efficacious dose of protein for these vulnerable patients. 

ASPEN’s mission is to improve patient care by advancing the science and practice of clinical nutrition and metabolism. Clearly, answering the question of how much protein is best for critically ill patients is consistent with that mission. On that basis, ASPEN has joined Dr. Daren Heyland in promoting the EFFORT trial (see www.criticalcarenutrition.com for more information) to interested members and colleagues.

A member of ASPEN and of the Leadership Council of ASPEN’s Critical Care Section, Dr. Heyland is a recognized leader in critical care nutrition research. He has proposed the EFFORT trial to answer the question of appropriate protein dose. Site participation in the EFFORT trial, planned to launch in January 2018, will require local ethics body approval and data entry by volunteers in global ICUs. The EFFORT trial will include randomization of individual patients to a protein target of either ≤1.2 g/kg/day or ≥2.2 g/kg/day. Over a period of 3 years, the trial will enroll approximately 4,000 adult patients to answer the question of which of these two common protein doses yields lower 60-day mortality, and secondarily shorter time to discharge alive.  Sites will receive a benchmarking report once the trial has ended.   

By the 2022 ASPEN Nutrition Science and Practice Conference, we hope that the answer to the important question about the optimal protein dose in critically ill patients will be clear. We need your support and participation to make this dream come true. Please check the www.criticalcarenutrition.com website for details. Get involved in enrolling ICU patients to this important trial.

References

  1. 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.). JPEN J Parenter Enteral Nutr.2016;40(2):159-211.
  2. Scheinkestel CD, Kar L, Marshall K, et al. Prospective randomized trial to assess caloric and protein needs of critically Ill, anuric, ventilated patients requiring continuous renal replacement therapy. Nutrition. 2003;19(11-12):909-916.
  3. Doig GS, Simpson F, Bellomo R, et al. Intravenous amino acid therapy for kidney function in critically ill patients: a randomized controlled trial. Intensive Care Med. 2015;41(7):1197-1208.
  4. Ferrie S, Allman-Farinelli M, Daley M, Smith K. Protein Requirements in the Critically Ill: A Randomized Controlled Trial Using Parenteral Nutrition. JPEN J Parenter Enteral Nutr. 2016;40(6):795-805.
  5. Rugeles SJ, Rueda JD, Diaz CE, Rosselli D. Hyperproteic hypocaloric enteral nutrition in the critically ill patient: A randomized controlled clinical trial. Indian J Crit Care Med. 2013;17(6):343-349.
  6. Clifton GL, Robertson CS, Contant CF. Enteral hyperalimentation in head injury. J Neurosurg. 1985;62(2):186-193.
  7. Compher C, Chittams J, Sammarco T, Nicolo M, Heyland DK. Greater Protein and Energy Intake May Be Associated With Improved Mortality in Higher Risk Critically Ill Patients: A Multicenter, Multinational Observational Study. Crit Care Med. 2017;45(2):156-163.
  8. Zusman O, Theilla M, Cohen J, Kagan I, Bendavid I, Singer P. Resting energy expenditure, calorie and protein consumption in critically ill patients: a retrospective cohort study. Crit Care. 2016;20(1):367.
  9. Braunschweig CL, Freels S, Sheean PM, et al. Role of timing and dose of energy received in patients with acute lung injury on mortality in the Intensive Nutrition in Acute Lung Injury Trial (INTACT): a post hoc analysis. Am J Clin Nutr. 2017;105(2):411-416.
  10. Puthucheary ZA, Rawal J, McPhail M, et al. Acute skeletal muscle wasting in critical illness. JAMA. 2013;310(15):1591-1600.
  11. Casaer MP, Wilmer A, Hermans G, Wouters PJ, Mesotten D, Van den Berghe G. Role of disease and macronutrient dose in the randomized controlled EPaNIC trial: a post hoc analysis. Am J Respir Crit Care Med. 2013;187(3):247-255.