Early enteral immunonutrition vs. parenteral nutrition in critically ill patients without severe sepsis: a randomized clinical trial.
OBJECTIVE
We compared early parenteral nutrition (PN) and early enteral immunonutrition (iEN) in critically ill patients, distinguishing those with and without severe sepsis or septic shock (SS) on admission to intensive care units (ICUs).


METHODS
Multicenter, randomized, unblinded clinical trial in 33 Italian general ICUs.


METHODS
The study included 326 patients, 287 of whom did not have SS on ICU admission. Eligibility criteria excluded the two tails in the spectrum of critical conditions, i.e., patients either too well or too ill. Of the patients recruited 160 were randomized to iEN (142 without SS) and 166 to PN (145 without SS).


METHODS
Patients were randomized to two arms: early iEN or early PN.


RESULTS
Primary endpoint was 28-day mortality for all patients and the occurrence of SS during ICU stay for patients admitted without such condition. While 28-day mortality did not differ between iEN and PN (15.6% vs. 15.1%), patients without SS who received iEN had fewer episodes of severe sepsis or septic shock (4.9% vs. 13.1%). ICU length of stay was 4 days shorter in patients given iEN.


CONCLUSIONS
Compared to parenteral nutrition iEN appears to be beneficial in critical patients without severe sepsis or septic shock. Parenteral nutrition in these patients should be abandoned, at least when enteral nutrition can be administered, even at an initial low caloric content.
Radrizzani
D
D
Istituto di Ricerche Farmacologiche Mario Negri, GiViTI Scientific Committee, 24020 Ranica, Italy.
Bertolini
G
G
Facchini
R
R
Simini
B
B
Bruzzone
P
P
Zanforlin
G
G
Tognoni
G
G
Iapichino
G
G
D016638:Critical Illness / Q000628:therapy; D004750:Enteral Nutrition; D005260:Female; D006801:Humans; D007167:Immunotherapy; D008297:Male; D008875:Middle Aged; D010288:Parenteral Nutrition; D018805:Sepsis / Q000628:therapy*; D013997:Time Factors