Clinical trial NCT03792087 - References

Surgery — Efficacy and Safety of SmofKabiven Peripheral Versus Compounded Emulsion

Citation(s)

•   Alwayn IP, Gura K, Nosé V, Zausche B, Javid P, Garza J, Verbesey J, Voss S, Ollero M, Andersson C, Bistrian B, Folkman J, Puder M
  Omega-3 fatty acid supplementation prevents hepatic steatosis in a murine model of nonalcoholic fatty liver disease. Pediatr Res. 2005 Mar;57(3):445-52. Epub 2005 Jan 19.
•   Bernstein LH
  The systemic inflammatory response syndrome C-reactive protein and transthyretin conundrum. Clin Chem Lab Med. 2007;45(11):1566-7; author reply 1568-9.
•   Boulétreau P, Chassard D, Allaouchiche B, Dumont JC, Auboyer C, Bertin-Maghit M, Bricard H, Ecochard R, Rangaraj J, Chambrier C, Schneid C, Cynober L
  Glucose-lipid ratio is a determinant of nitrogen balance during total parenteral nutrition in critically ill patients: a prospective, randomized, multicenter blind trial with an intention-to-treat analysis. Intensive Care Med. 2005 Oct;31(10):1394-400. Epub 2005 Aug 24.
•   Braga M, Ljungqvist O, Soeters P, Fearon K, Weimann A, Bozzetti F; ESPEN
  ESPEN Guidelines on Parenteral Nutrition: surgery. Clin Nutr. 2009 Aug;28(4):378-86. doi: 10.1016/j.clnu.2009.04.002. Epub 2009 May 21.
•   Calder PC
  n-3 fatty acids, inflammation, and immunity--relevance to postsurgical and critically ill patients. Lipids. 2004 Dec;39(12):1147-61. Review.
•   Chinese medical clinical guidelines parenteral enteral nutrition 2008, edited by Chinese Medical Association, People's Medical Publishing House
  
•   Chowdary KV, Reddy PN
  Parenteral nutrition: Revisited. Indian J Anaesth. 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637.
•   Fresenius Kabi
  SomfKabiven Peripheral, emulsion for infusion. Summary of Product Characteristics, dated September.29. 2009
•   Grimm H, Mertes N, Goeters C, Schlotzer E, Mayer K, Grimminger F, Fürst P
  Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006 Feb;45(1):55-60. Epub 2005 Jul 22.
•   Gura KM, Duggan CP, Collier SB, Jennings RW, Folkman J, Bistrian BR, Puder M
  Reversal of parenteral nutrition-associated liver disease in two infants with short bowel syndrome using parenteral fish oil: implications for future management. Pediatrics. 2006 Jul;118(1):e197-201.
•   Helmut Grimm, A balanced lipid emulsion-A new concept in parenteral nutrition
  Clinical Nutrition Supplements (2005) 1, 25-30.
•   Mayer K, Gokorsch S, Fegbeutel C, Hattar K, Rosseau S, Walmrath D, Seeger W, Grimminger F
  Parenteral nutrition with fish oil modulates cytokine response in patients with sepsis. Am J Respir Crit Care Med. 2003 May 15;167(10):1321-8. Epub 2003 Feb 25.
•   McClave SA, Martindale RG, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G; A
  S.P.E.N. Board of Directors; American College of Critical Care Medicine; Society of Critical Care Medicine. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):277-316. doi: 10.1177/0148607109335234.
•   Novak TE, Babcock TA, Jho DH, Helton WS, Espat NJ
  NF-kappa B inhibition by omega -3 fatty acids modulates LPS-stimulated macrophage TNF-alpha transcription. Am J Physiol Lung Cell Mol Physiol. 2003 Jan;284(1):L84-9. Epub 2002 Aug 30.
•   Pluess TT, Hayoz D, Berger MM, Tappy L, Revelly JP, Michaeli B, Carpentier YA, Chioléro RL
  Intravenous fish oil blunts the physiological response to endotoxin in healthy subjects. Intensive Care Med. 2007 May;33(5):789-797. doi: 10.1007/s00134-007-0591-5. Epub 2007 Mar 22. Erratum in: Intensive Care Med. 2007 Jul;33(7):1310. Intensive Care Med. 2007 Jul;33(7):1310.
•   Puder M, Valim C, Meisel JA, Le HD, de Meijer VE, Robinson EM, Zhou J, Duggan C, Gura KM
  Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury. Ann Surg. 2009 Sep;250(3):395-402. doi: 10.1097/SLA.0b013e3181b36657.
•   Sergi G, Coin A, Enzi G, Volpato S, Inelmen EM, Buttarello M, Peloso M, Mulone S, Marin S, Bonometto P
  Role of visceral proteins in detecting malnutrition in the elderly. Eur J Clin Nutr. 2006 Feb;60(2):203-9.
•   Shenkin A
  Serum prealbumin: Is it a marker of nutritional status or of risk of malnutrition? Clin Chem. 2006 Dec;52(12):2177-9.
•   Singer P, Berger MM, Van den Berghe G, Biolo G, Calder P, Forbes A, Griffiths R, Kreyman G, Leverve X, Pichard C, ESPEN
  ESPEN Guidelines on Parenteral Nutrition: intensive care. Clin Nutr. 2009 Aug;28(4):387-400. doi: 10.1016/j.clnu.2009.04.024. Epub 2009 Jun 7.
•   SSPC
  Intralipid 20%, Summary of Product Characteristics, dated 14 February 2007
•   SSPC
  Novamin 11.4%, Summary of Product Characteristics, dated 01 December 2013
•   Xiong J, Zhu S, Zhou Y, Wu H, Wang C
  Regulation of omega-3 fish oil emulsion on the SIRS during the initial stage of severe acute pancreatitis. J Huazhong Univ Sci Technolog Med Sci. 2009 Feb;29(1):35-8. doi: 10.1007/s11596-009-0107-3. Epub 2009 Feb 18.
•   Young GA, Collins JP, Hill GL
  Plasma proteins in patients receiving intravenous amino acids or intravenous hyperalimentation after major surgery. Am J Clin Nutr. 1979 Jun;32(6):1192-9.
•   Young GA, Hill GL
  A controlled study of protein-sparing therapy after excision of the rectum: effects of intravenous amino acids and hyperalimentation on body composition and plasma amino acids. Ann Surg. 1980 Aug;192(2):183-91.
•   Young GA, Hill GL
  Assessment of protein-calorie malnutrition in surgical patients from plasma proteins and anthropometric measurements. Am J Clin Nutr. 1978 Mar;31(3):429-35.

Efficacy & Safety of SmofKabiven Peripheral vs Compounded Emulsion: A Randomized, Active-Controlled, Open-Labelled, Multi-Centre Study in Adult Surgical Patients Requiring Parenteral Nutrition

Details for clinical trial NCT03792087