Pontes-Arruda A, Martins LF, de Lima SM, Isola AM, Toledo D, Rezende E, Maia M, Magnan GB, Gla And Antioxidants Role In Sepsis Treatment Study Group II.; Crit Care. 2011 Jun 9;15(3):R144.
INTRODUCTION: Enteral nutrition (EN) with eicosapentaenoic acid (EPA)/ gamma-linolenic acid (GLA) is recommended for mechanically ventilated patients with severe lung injury. EPA/GLA has anti-inflammatory benefits as is evident by its association with reduction in pulmonary inflammation, improvements in oxygenation, and clinical outcomes in severe forms of acute lung injury. This study was a prospective, multicenter, randomized, double-blinded and controlled trial designed to investigate if EPA/GLA could play a role in patients with early sepsis (SIRS with confirmed or presumed infection and without any organ dysfunction), by reducing the progression of the disease to severe sepsis (sepsis associated with at least one organ failure) or septic shock (sepsis associated with hypotension despite adequate fluid resuscitation). Secondary outcomes included development of individual organ failures, ICU and hospital stay, use of mechanical ventilation, and 28-days all-cause mortality.
METHODS: Randomization was concealed and patients were allocated to receive for 7 days either an EPA/GLA diet or an isocaloric, isonitrogenous control diet, not enhanced with lipids. Diets were continuously tube fed at a minimum of 75% of basal energy expenditure (BEE) x 1.3. To evaluate the progression to severe sepsis/septic shock a daily screening of individual organ failures was performed. All clinical outcomes were recorded during a 28-day follow-up period.
RESULTS: 115 patients in the early stages of sepsis requiring EN were included, out of which 106 were considered evaluable. Intent to treat (ITT) analysis demonstrated that patients fed EPA/GLA developed less severe sepsis/septic shock (26.3% vs. 50%, p=.0259), with similar results observed for the evaluable patients (26.4% vs. 50.9%, p=.0217). The ITT analysis demonstrated that patients in the study group developed less cardiovascular (36.2% vs. 21%, p=.0381) and respiratory failures (39.6% vs. 24.6%, p=.0362). Similarly fewer evaluable patients developed cardiovascular (20.7% vs. 37.7%, p=.03), and respiratory failures (26.4% vs. 39.6%, p=.04). The percentage of EPA/GLA patients requiring invasive mechanical ventilation was reduced as compared with controls (ITT: 18.9% vs. 33.9%, p=.394; Evaluable: 17.5% vs. 34.5%, p=.295). Patients nourished with EPA/GLA remain fewer days at the ICU compared to the control population (ITT: 21.1 vs. 14.7 ICU-free days, p<.0001; Evaluable: 20.8 vs. 14.3 ICU-free days, p<.0001), and fewer days at the hospital (ITT: 19.5 vs. 10.3 Hospital-free days, p<.0001; Evaluable: 19.1 vs. 10.2 Hospital-free days, p<.001). No difference was observed in the 28-days all-cause mortality (ITT: 26.2% EPA/GLA vs. 27.6% control, p=.72; Evaluable: 26.4 EPA/GLA vs. 30.18 control, p=.79).
CONCLUSIONS: These data suggest that EPA/GLA may play a beneficial role for enterally fed patients in the early stages of sepsis without associated organ dysfunction, by contributing to slow the progression of sepsis-related organ dysfunction, specially cardiovascular and respiratory dysfunctions. Trial registration: Clinical trials.gov NCT00329680.
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