The Effect of Higher Protein Dosing in Critically Ill Patients: a Multicenter Randomized Trial

Positive, neutral, or negative, the results of the EFFORTcombo study will inform the clinical practice in ICU settings around the world. If positive, because of the pragmatic, multicentre nature of this trial, results will be broadly applicable to all critically ill patients worldwide. If the results are negative, it will be ensured that patients no longer receive high‐dose protein/amino acid admixtures or possibly, combined EN/PN. As it relates to critical care nutrition practice in general, there is a long history of practice‐changing initiatives. A process of synthesizing (in the form of evidence‐based clinical practice guidelines) and disseminating best practice ideas (in the form of web‐based repository of tools and information [see www.criticalcarenutrition.com]) was established. Over the past several years, this program of research with leaders of the American Society of Parenteral and Enteral Nutrition (ASPEN) and this specific protocol at the annual Clinical Nutrition Week with society leaders, researchers, and the clinical nutrition community at large has been discussed. Partnership with ASPEN will further facilitate both, recruitment initiatives and, importantly, the knowledge translation initiatives. These efforts will increase the likelihood of the uptake of EFFORT results across the world. This study has both the potential to answer a high‐priority clinical question and also transform the new approach in clinical nutrition research. It further represents a unique collaboration between ASPEN, its global partners, and the Clinical Evaluation Research Unit, a methodological support center based in Kingston, Ontario, Canada and managed by Dr. Daren Heyland. If successful, this type of collaboration sets an important precedent for how this community may approach additional research questions related to clinical nutrition. Nested within this larger volunteer‐driven registry trial, the aim is to complete a significant sub‐study that will establish the role of combined EN/PN in these nutritionally high‐risk patients. This protocol pertains to the specifics of this sub‐study of combined EN/PN. At the end of the trial, the data from this sub‐study will be merged into the results of the overall parent EFFORT Trial (where data points are similar).