Therapy
Effects of enteral feeding with eicosapentaenoic acid, gamma-linolenic acid, and antioxidants in mechanically ventilated patients with severe sepsis and septic shock
This review may be edited
Summary
Posted By: Elizabeth Sweetman
E-Mail: easweetm@nsccahs.health.nsw.gov.au
Posted Date: 22/03/09
Title: Effects of enteral feeding with eicosapentaenoic acid, gamma-linolenic acid, and antioxidants in mechanically ventilated patients with severe sepsis and septic shock
Authors: Pontes-Arruda A, Arag„o AM, Albuquerque JD
Reference: Crit Care Med. 2006 Sep;34(9):2325-33
Link: Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract: OBJECTIVES: Enteral diets enriched with eicosapentaenoic acid (EPA), gamma-linolenic acid (GLA), and antioxidants have previously been shown to improve outcomes in patients with acute respiratory distress syndrome. Several studies using animal models of sepsis demonstrate that enteral nutrition enriched with omega-3 fatty acids reduces mortality rate. This study investigated whether an enteral diet enriched with EPA, GLA, and antioxidant vitamins can improve outcomes and reduce 28-day all-cause mortality in patients with severe sepsis or septic shock requiring mechanical ventilation.
DESIGN: Prospective, double-blind, placebo-controlled, randomized trial.
SETTING: Three different intensive care units of a tertiary hospital in Brazil.
PATIENTS: The study enrolled 165 patients.
INTERVENTIONS: Patients were randomized to be continuously tube-fed with either a diet enriched with EPA, GLA, and elevated antioxidants or an isonitrogenous and isocaloric control diet, delivered at a constant rate to achieve a minimum of 75% of basal energy expenditure x 1.3 during a minimum of 4 days.
MEASUREMENTS AND MAIN RESULTS: Patients were monitored for 28 days. Patients who were fed with the study diet experienced a significant reduction in mortality rate compared with patients fed with the control diet, the absolute mortality reduction amounting to 19.4% (p = .037). The group who received the study diet also experienced significant improvements in oxygenation status, more ventilator-free days (13.4 +/- 1.2 vs. 5.8 +/- 1.0, p < .001), more intensive care unit (ICU)-free days (10.8 +/- 1.1 vs. 4.6 +/- 0.9, p < .001), and a lesser development of new organ dysfunctions (p < .001).
CONCLUSIONS: In patients with severe sepsis or septic shock and requiring mechanical ventilation and tolerating enteral nutrition, a diet enriched with EPA, GLA, and elevated antioxidants contributed to better ICU and hospital outcomes and was associated with lower mortality rates.
 
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? ( Was allocation concealment maintained?)
Unclear.
Method of randomization not stated and therefore allocation concealment unclear.
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
No.
37.575%(62 of the 165 enrolled patients) were excluded from final analysis.
Reasons for excluding these patients from analysis includes: unable to meet caloric goals, extubation from ventilator, patient pulled feeding tube, withdrawal by physician and death.
Outcomes for all of these 62 patients should have been reported.
Significant loss to follow-up is considered a major validity flaw.
2b. Were patients analyzed in the groups to which they were randomized?
Yes.
3. Were patients, health workers, and study personnel blind to treatment?
Yes, however the blinding method is not documented.
4. Were the groups similar at the start of the trial?
Table 1 only reports differences between the 103 patients on whom outcomes were reported. Baseline balance should have been reported for all patients randomised.
There may be more patients with septic shock and cardiovascular organ failure in the EPA+GLA arm.
5. Aside from the experimental intervention, were the groups treated equally?
Yes.
What are the Results?
1. How large was the treatment effect?
Due to significant loss to follow-up (37%), we recommend that the outcomes reported in this paper should not be considered [Gord].
2. How precise was the estimate of the treatment effect?
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
2. Were all clinically important outcomes considered?
3. Are the likely treatment benefits worth the potential harms and costs?

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Effects of enteral feeding with eicosapentaenoic acid, gamma-linolenic acid, and antioxidants in mechanically ventilated patients with severe sepsis and septic shock

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