OBJECTIVE: To compare the effect of early enteral feeding using immune-enhancing (IE) vs. non-immune-enhancing (NIE) formulas on cytokines in children with septic shock. DESIGN AND SETTING: A single-center, randomized, blinded controlled trial in a pediatric intensive care unit of a university hospital. PATIENTS: We randomized 38 patients with septic shock to either IE or NIE. Feedings were advanced to a target volume of energy intake equal to 1/2, 1, 5/4, 6/4, and 6/4 of the predicted basal metabolic rate on days 1-5, respectively. MEASUREMENTS AND RESULTS:Interleukins (IL) 1beta, 6, and 8, tumor necrosis factor alpha, C-reactive protein, Pediatric Risk of Mortality (PRISM) score, survival, secondary infections, length of stay, andmechanical ventilation were compared within and between the two groups. Actual mean energy and protein intakes did not differ between the two groups and the caloric-protein balance was not correlated to cytokine levels. On day 5 IL-6 levels were significantly lower (11.8+/-2.4 vs. 38.3+/-3.6) and IL-8 significantly higher in the IE than in the NIE group (65.4+/-17 vs. 21+/-2.5). After 5 days of nutritional support a significant decrease in IL-6 levels was recorded only in group IE (mean of paired differences 39.4+/-3 pg/ml). In multivariate regression analysis the variation in cytokines was independently correlated only to PRISM (R(2)=-0.50), but pediatric intensive care unit outcome endpoints did not differ between the two groups. CONCLUSIONS: Early IE nutrition may modulate cytokines in children with septic shock, but there is no evidence that this immunomodulation has any impact on short-term outcome.
RCT Entities:
OBJECTIVE: To compare the effect of early enteral feeding using immune-enhancing (IE) vs. non-immune-enhancing (NIE) formulas on cytokines in children with septic shock. DESIGN AND SETTING: A single-center, randomized, blinded controlled trial in a pediatric intensive care unit of a university hospital. PATIENTS: We randomized 38 patients with septic shock to either IE or NIE. Feedings were advanced to a target volume of energy intake equal to 1/2, 1, 5/4, 6/4, and 6/4 of the predicted basal metabolic rate on days 1-5, respectively. MEASUREMENTS AND RESULTS: Interleukins (IL) 1beta, 6, and 8, tumor necrosis factor alpha, C-reactive protein, Pediatric Risk of Mortality (PRISM) score, survival, secondary infections, length of stay, and mechanical ventilation were compared within and between the two groups. Actual mean energy and protein intakes did not differ between the two groups and the caloric-protein balance was not correlated to cytokine levels. On day 5 IL-6 levels were significantly lower (11.8+/-2.4 vs. 38.3+/-3.6) and IL-8 significantly higher in the IE than in the NIE group (65.4+/-17 vs. 21+/-2.5). After 5 days of nutritional support a significant decrease in IL-6 levels was recorded only in group IE (mean of paired differences 39.4+/-3 pg/ml). In multivariate regression analysis the variation in cytokines was independently correlated only to PRISM (R(2)=-0.50), but pediatric intensive care unit outcome endpoints did not differ between the two groups. CONCLUSIONS: Early IE nutrition may modulate cytokines in children with septic shock, but there is no evidence that this immunomodulation has any impact on short-term outcome.
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