The Effect of Higher Protein Dosing in Critically Ill Patients

Summary

Participation Requirements

Description

The EFFORT Study is a multi-center, pragmatic, volunteer-driven, registry-based, randomized, clinical trial of 4000 nutritionally high-risk critically ill patients in the intensive care unit (ICU). We anticipate over 100 sites participating internationally, with each site enrolling a minimum of 30 p...

The EFFORT Study is a multi-center, pragmatic, volunteer-driven, registry-based, randomized, clinical trial of 4000 nutritionally high-risk critically ill patients in the intensive care unit (ICU). We anticipate over 100 sites participating internationally, with each site enrolling a minimum of 30 patients. Patients will be randomized to 1 of 2 treatment groups: a usual prescription (?1.2 g/kg/d) or a higher prescription (?2.2 g/kg/d) of protein. Other than the protein amount the patient is randomized to the remainder of care provided to randomized patient will be at the discretion of ICU providers. In both groups, targets will be achieved through any combination of enteral nutrition (high protein content in high group if available), protein supplements, and parenteral nutrition or amino acids only (as clinically available). The only difference between the 2 groups is the protein targets that are set. Similar efforts should be used in both groups to achieve at least 80% of these targets. The remainder of care provided to eligible patients will be at the discretion of ICU providers. The investigator has posed two research questions: Primary Research Question: In critically ill patients with nutrition 'risk factors', what is the effect of prescribing a higher dose (?2.2 grams/kg/day) of protein/amino acid administration compared to a usual dose prescribed ?1.2 gram/kg/day on 60 day mortality? Secondary Research Question: In critically ill patients with nutrition 'risk factors', what is the effect of prescribing a higher dose (?2.2 grams/kg/day) of protein/amino acid administration compared to patients prescribed ?1.2 gram/kg/day on time to discharge alive from hospital? The proposed hypothesis: Compared to receiving usual dose of protein/amino acids, the administration of a higher dose of protein/amino acids (a consequence of having a higher prescription) to nutritionally high-risk critically ill patients will be associated with improved survival and a quicker rate of recovery.

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