title: Early enteral supplementation with key pharmaconutrients improves Sequential Organ Failure Assessment score in critically ill patients with sepsis: outcome of a randomized, controlled, double-blind trial.
abstract: OBJECTIVE
  To assess the safety and efficacy of an early enteral pharmaconutrition supplement containing glutamine dipeptides, antioxidative vitamins and trace elements, and butyrate in critically ill, septic patients.
  
  
  METHODS
  A prospective, randomized, controlled, double-blind clinical trial.
  
  
  METHODS
  Adult intensive care unit in a university hospital.
  
  
  METHODS
  Fifty-five critically ill, septic patients requiring enteral feeding.
  
  
  METHODS
  Patients received either an enteral supplement (500 mL of Intestamin, Fresenius Kabi) containing conditionally essential nutrients or a control solution via the nasogastric route for up to 10 days. Inclusion occurred within 24 hrs of intensive care unit admission. Additionally, patients received enteral feeding with an immunonutrition formula (experimental group) or standard formula (control group) initiated within 48 hrs after enrollment.
  
  
  RESULTS
  Organ dysfunction was assessed by daily total Sequential Organ Failure Assessment (SOFA) score over the 10-day study period in both patient groups. Patients receiving the experimental supplement showed a significantly faster decline in the regression slopes of delta daily total SOFA score over time compared with control. The difference between the regression coefficients of the two slopes was significant irrespective of the level of analysis: intent to treat -0.32 vs. -0.14, p < .0001; per protocol -0.34 vs. -0.14, p < .0001; and completers (patients receiving > or = 80% of the calculated caloric target over a period of 6 days), -0.26 vs. -0.16, p = .0005. Vitamin C, as a marker of supplement absorption, increased from 10.6 (1.9-159.4) micromol/L (normal range 20-50 micromol/L) on day 1 to 58.7 (5.4-189.9) micromol/L by day 3 (p = .002) in the intervention group but remained below the normal range in the control group 17.0 (2.8-78.5) on day 1 and 14.3 (2.4-179.6) on day 3. Serum levels of glycine, serine, arginine, ornithine, vitamin E, and beta-carotene all increased significantly with treatment in the supplementation group.
  
  
  CONCLUSIONS
  In medical patients with sepsis, early enteral pharmaconutrition with glutamine dipeptides, vitamin C and E, beta-carotene, selenium, zinc, and butyrate in combination with an immunonutrition formula results in significantly faster recovery of organ function compared with control.
authors.affiliation: Department of Adult Critical Care Medicine, Guy's and St. Thomas' Hospital, London, United Kingdom. richard.beale@gstt.nhs.uk
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Beale
authors.forename: Tony
authors.initials: T
authors.lastname: Sherry
authors.forename: Katie
authors.initials: K
authors.lastname: Lei
authors.forename: Laura
authors.initials: L
authors.lastname: Campbell-Stephen
authors.forename: Julie
authors.initials: J
authors.lastname: McCook
authors.forename: John
authors.initials: J
authors.lastname: Smith
authors.forename: Werner
authors.initials: W
authors.lastname: Venetz
authors.forename: Birgit
authors.initials: B
authors.lastname: Alteheld
authors.forename: Peter
authors.initials: P
authors.lastname: Stehle
authors.forename: Heinz
authors.initials: H
authors.lastname: Schneider
mesh_terms: D000596:Amino Acids / Q000097:blood; D000975:Antioxidants / Q000627:therapeutic use; D019587:Dietary Supplements; D004311:Double-Blind Method; D004750:Enteral Nutrition; D005260:Female; D005973:Glutamine / Q000627:therapeutic use; D006801:Humans; D007408:Intestinal Absorption; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009102:Multiple Organ Failure / Q000175:diagnosis* / Q000209:etiology / Q000276:immunology / Q000628:therapy*; D011446:Prospective Studies; D018805:Sepsis / Q000150:complications / Q000628:therapy*; D014131:Trace Elements / Q000097:blood / Q000627:therapeutic use; D016896:Treatment Outcome; D014815:Vitamins / Q000097:blood / Q000627:therapeutic use
chemical_list: D000596:Amino Acids; D000975:Antioxidants; D014131:Trace Elements; D014815:Vitamins; D005973:Glutamine