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 intensive care unit (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 hypothesise that
critically ill patients at high nutritional risk may benefit from such a combined approach during their stay on the ICU. Therefore, we aim to test if an early combination of EN and high-
protein PN (EN+PN) is effective in reaching energy 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 randomised to either high (≥2·2 g/kg per d) or low
protein (≤1·2 g/kg per 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 with international guidelines in both groups. Efforts will be made to reach nutrition goals within 48-96 h. 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.