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. DESIGN: A prospective, randomized, controlled, double-blind clinical trial. SETTING:Adult intensive care unit in a university hospital. PATIENTS: Fifty-fivecritically ill, septic patients requiring enteral feeding. INTERVENTIONS: 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. MEASUREMENTS AND MAIN 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.
RCT Entities:
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, septicpatients. DESIGN: A prospective, randomized, controlled, double-blind clinical trial. SETTING: Adult intensive care unit in a university hospital. PATIENTS: Fifty-five critically ill, septicpatients requiring enteral feeding. INTERVENTIONS: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. MEASUREMENTS AND MAIN 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: Scott L Weiss; Mark J Peters; Waleed Alhazzani; Michael S D Agus; Heidi R Flori; David P Inwald; Simon Nadel; Luregn J Schlapbach; Robert C Tasker; Andrew C Argent; Joe Brierley; Joseph Carcillo; Enitan D Carrol; Christopher L Carroll; Ira M Cheifetz; Karen Choong; Jeffry J Cies; Andrea T Cruz; Daniele De Luca; Akash Deep; Saul N Faust; Claudio Flauzino De Oliveira; Mark W Hall; Paul Ishimine; Etienne Javouhey; Koen F M Joosten; Poonam Joshi; Oliver Karam; Martin C J Kneyber; Joris Lemson; Graeme MacLaren; Nilesh M Mehta; Morten Hylander Møller; Christopher J L Newth; Trung C Nguyen; Akira Nishisaki; Mark E Nunnally; Margaret M Parker; Raina M Paul; Adrienne G Randolph; Suchitra Ranjit; Lewis H Romer; Halden F Scott; Lyvonne N Tume; Judy T Verger; Eric A Williams; Joshua Wolf; Hector R Wong; Jerry J Zimmerman; Niranjan Kissoon; Pierre Tissieres Journal: Intensive Care Med Date: 2020-02 Impact factor: 17.440
Authors: German Kamalov; Robert A Ahokas; Wenyuan Zhao; Tieqiang Zhao; Atta U Shahbaz; Patti L Johnson; Syamal K Bhattacharya; Yao Sun; Ivan C Gerling; Karl T Weber Journal: J Cardiovasc Pharmacol Date: 2010-03 Impact factor: 3.105
Authors: Mireille F M van Stijn; Gerdien C Ligthart-Melis; Petra G Boelens; Peter G Scheffer; Tom Teerlink; Jos W R Twisk; Alexander P J Houdijk; Paul A M van Leeuwen Journal: World J Gastroenterol Date: 2008-12-07 Impact factor: 5.742