drugset / Trial / NCT00396461
ICULIP, Influence of Two Lipid Emulsions in the Nosocomial Infection in Critical Patients
RandomizedParallel-groupDouble-blindTreatment
Summary
This study aims to analyse the effect of two total parenteral nutrition diets with lipid emulsions of different compositions on the incidence of nosocomial infection in critical patients. One diet will contain an MCT/LCT emulsion concentrated to 20% (50:50 ratio) and the other will comprise an MCT/LCT/fish oil emulsion (50:40:10 ratio). The secondary objective of this study is to analyse mortality in hospital and up to 6 months of discharge.
Timeline
- Start
- 2006-11
- Primary completion
- 2010-09
- Completion
- 2011-02
Publications
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- Background Calder PC, Sherrington EJ, Askanazi J, Newsholme EA. Inhibition of lymphocyte proliferation in vitro by two lipid emulsions with different fatty acid compositions. Clin Nutr. 1994 Apr;13(2):69-74. doi: 10.1016/0261-5614(94)90062-0.
- Background Clarke PJ, Ball MJ, Hands LJ, Dennison AR, Tunbridge A, White K, Kettlewell MG. Use of a lipid containing medium chain triglycerides in patients receiving TPN: a randomized prospective trial. Br J Surg. 1987 Aug;74(8):701-4. doi: 10.1002/bjs.1800740818.
- Background Barton RG. Nutrition support in critical illness. Nutr Clin Pract. 1994 Aug;9(4):127-39. doi: 10.1177/0115426594009004127.
- Background Suchner U, Katz DP, Furst P, Beck K, Felbinger TW, Senftleben U, Thiel M, Goetz AE, Peter K. Effects of intravenous fat emulsions on lung function in patients with acute respiratory distress syndrome or sepsis. Crit Care Med. 2001 Aug;29(8):1569-74. doi: 10.1097/00003246-200108000-00012.
- Background Gogos CA, Kalfarentzos FE, Zoumbos NC. Effect of different types of total parenteral nutrition on T-lymphocyte subpopulations and NK cells. Am J Clin Nutr. 1990 Jan;51(1):119-22. doi: 10.1093/ajcn/51.1.119.
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- Background Calder PC. Long-chain n-3 fatty acids and inflammation: potential application in surgical and trauma patients. Braz J Med Biol Res. 2003 Apr;36(4):433-46. doi: 10.1590/s0100-879x2003000400004. Epub 2003 Apr 8.
- Background Gadek JE, DeMichele SJ, Karlstad MD, Pacht ER, Donahoe M, Albertson TE, Van Hoozen C, Wennberg AK, Nelson JL, Noursalehi M. Effect of enteral feeding with eicosapentaenoic acid, gamma-linolenic acid, and antioxidants in patients with acute respiratory distress syndrome. Enteral Nutrition in ARDS Study Group. Crit Care Med. 1999 Aug;27(8):1409-20. doi: 10.1097/00003246-199908000-00001.
- Background Weiss G, Meyer F, Matthies B, Pross M, Koenig W, Lippert H. Immunomodulation by perioperative administration of n-3 fatty acids. Br J Nutr. 2002 Jan;87 Suppl 1:S89-94. doi: 10.1079/bjn2001461.
- Background Koller M, Senkal M, Kemen M, Konig W, Zumtobel V, Muhr G. Impact of omega-3 fatty acid enriched TPN on leukotriene synthesis by leukocytes after major surgery. Clin Nutr. 2003 Feb;22(1):59-64. doi: 10.1054/clnu.2002.0592.
- Background Tsekos E, Reuter C, Stehle P, Boeden G. Perioperative administration of parenteral fish oil supplements in a routine clinical setting improves patient outcome after major abdominal surgery. Clin Nutr. 2004 Jun;23(3):325-30. doi: 10.1016/j.clnu.2003.07.008.
- Background ASPEN Board of Directors: Guidelines for the use of parenteral and enteral nutrition in adults and pediatric patients. JPEN 2001
- Background Carpentier YA, Van Gossum A, Dubois D, Deckeibaum R. Lipid Metabolism in Parenteral Nutrition. In: Wilmore DW, Carpentier YA (Eds). Metabolic Support of the Critically III Patient. Berlin, Springer-Veriag 1993, pp 35-74
- Background Driscoll DF, Adolph M, Bistrian BR. Lipid emulsions in parenteral nutrition. In: Rombeau JL, Rolandelli R, eds. Parenteral nutrition. Philadelphia: W. B. Saunders Company; 2000:35-39.
- Background Santoli D, Zurier RB. Prostaglandin E precursor fatty acids inhibit human IL-2 production by a prostaglandin E-independent mechanism. J Immunol. 1989 Aug 15;143(4):1303-9.
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- Background Grau T, Ruiz de Adana JC, Zubillaga S, Fuerte S, Giron C. [Randomized study of two different fat emulsions in total parenteral nutrition of malnourished surgical patients;effect of infectious morbidity and mortality]. Nutr Hosp. 2003 May-Jun;18(3):159-66. Spanish.
- Background Grimminger F, Seeger W, Mayer K. Use of n-3 fatty acid-containing lipid emulsions in the intensive care unit environment: the clinician's view. Clinical Nutrition 2002, 21, Supplement 2: 23-29.
- Background Wichmann MW, Morlion B, Czarnetzki H-D, Thul P, Jauch K-W. Reduction of length of postoperative stay by fish oil containing lipid emulsion - data from a multicenter trial. Clinical Nutrition 2004, 23: 1471
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | MCT/LCT (1:1) | Unknown | 20 % | — |
| Subject | MCT/LCT/omega-3 (5:4:1) | Unknown | 20 % | — |