While medical nutrition therapy is an essential part of the care for critically ill patients, uncertainty exists about the right form, dosage, timing and route in relation to the phases of critical illness. As enteral nutrition (EN) is often withheld or interrupted during the ICU stay, combined EN and parenteral nutrition (PN) may represent an effective and safe option to achieve energy and protein goals as recommended by international guidelines. We hypothesize that critically ill patients at high nutritional risk may benefit from such a combined approach during their stay on the intensive care unit (ICU). Therefore, we aim to test if an early combination of EN and high-protein PN (EN+PN) is effective in reaching calorie and protein goals in patients at high nutritional risk, while avoiding overfeeding. This approach will be tested in the here presented EFFORTcombo trial. Nutritionally high-risk ICU patients will be randomized to either high (≥2.2 mg/kg/d) or low protein (≤1.2 mg/kg/d). In the high protein group, the patients will receive EN+PN, in the low protein group, patients will be given EN alone. EN will be started in accordance to international guidelines in both groups. Efforts will be made to reach nutrition goals within 48-96 hours. The efficacy of the proposed nutritional strategy will be tested as an innovative approach by functional outcomes at ICU- and hospital-discharge, as well as at a 6-month follow-up.
Keywords: Critical Illness; Enteral Nutrition; Goals; High Protein Diet; Malnutrition; Nutrition Therapy; Nutritional Status; Outcome Assessment; Parenteral Nutrition.