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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.
Crit Care Med. 2008 Jan; 36(1):131-44.CC

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.

DESIGN

A prospective, randomized, controlled, double-blind clinical trial.

SETTING

Adult intensive care unit in a university hospital.

PATIENTS

Fifty-five critically 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.

Authors+Show Affiliations

Department of Adult Critical Care Medicine, Guy's and St. Thomas' Hospital, London, United Kingdom. richard.beale@gstt.nhs.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18007263

Citation

Beale, Richard J., et al. "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." Critical Care Medicine, vol. 36, no. 1, 2008, pp. 131-44.
Beale RJ, Sherry T, Lei K, et al. 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. Crit Care Med. 2008;36(1):131-44.
Beale, R. J., Sherry, T., Lei, K., Campbell-Stephen, L., McCook, J., Smith, J., Venetz, W., Alteheld, B., Stehle, P., & Schneider, H. (2008). 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. Critical Care Medicine, 36(1), 131-44.
Beale RJ, et al. 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. Crit Care Med. 2008;36(1):131-44. PubMed PMID: 18007263.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Beale,Richard J, AU - Sherry,Tony, AU - Lei,Katie, AU - Campbell-Stephen,Laura, AU - McCook,Julie, AU - Smith,John, AU - Venetz,Werner, AU - Alteheld,Birgit, AU - Stehle,Peter, AU - Schneider,Heinz, PY - 2007/11/17/pubmed PY - 2008/2/13/medline PY - 2007/11/17/entrez SP - 131 EP - 44 JF - Critical care medicine JO - Crit Care Med VL - 36 IS - 1 N2 - 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-five critically 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. SN - 1530-0293 UR - https://www.unboundmedicine.com/medline/citation/18007263/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_ L2 - https://dx.doi.org/10.1097/01.CCM.0000297954.45251.A9 DB - PRIME DP - Unbound Medicine ER -