Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition
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Historically, randomized controlled trials (RCTs) in critical care have used mortality as the primary outcome, yet most show no effect on this outcome. Therefore, there has been a shift in the literature to focus on alternative outcomes. This review aimed to describe primary outcomes selected in RCTs of nutrition interventions in critical illness. ⋯ Morbidity was the most frequently reported outcome category in RCTs that evaluated a nutrition intervention in critically ill adults, with mortality least frequent. Power calculations were only reported in 58% of included studies. Trials were more likely to show a significant result when an outcome other than mortality was the primary outcome.
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The current recommendation for protein dose in critically ill patients is 1.2-2.0 g/kg/d. Despite this recommendation, there is significant variation in the amount of protein prescribed and delivered worldwide. We contend clinical equipoise, or a state of genuine uncertainty about 2 (dosing) strategies, exists because guideline-based recommendations for protein dose in critically ill patients are rooted in a weak evidentiary base, leaving the clinician with no good basis for choosing a lower or higher protein dose. We outline evidence for and against high protein dose and introduce a pragmatic, registry-based, multicenter, randomized controlled trial, known as EFFORT, which aims to resolve the high vs low protein dose controversy.