A phase II randomized placebo-controlled trial of omega-3 fatty acids for the treatment of acute lung injury

Critical Care Medicine

Volumn 39, Issue 7, 2011, Pages 1655-1662

  Stapleton, Renee D ^a   Martin, Thomas R ^b   Weiss, Noel S ^b   Crowley, Joseph J ^c   Gundel, Stephanie J ^b   Nathens, Avery B ^d   Akhtar, Saadia R ^e   Ruzinski, John T ^b   Caldwell, Ellen ^b   Curtis, J Randall ^b   Heyland, Daren K ^f   Watkins, Timothy R ^b,g   Parsons, Polly E ^a   Martin, Julie M ^a   Wurfel, Mark M ^b   Hallstrand, Teal S ^b   Sims, Kathryn A ^b   Neff, Margaret J ^b  

^a UNIVERSITY OF VERMONT COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c Saint Alphonsus Regional Medical Center   (United States)

^d UNIVERSITY OF TORONTO   (Canada)

^e St Luke's Boise Medical Center   (United States)

^f QUEEN S UNIVERSITY   (Canada)

^g PUGET SOUND BLOOD CENTER   (United States)

Author keywords

acute lung injury; acute respiratory distress syndrome; docosahexaenoic acid; eicosapentaenoic acid; fish oils; randomized controlled trial

Indexed keywords

DOCOSAHEXANOIC ACID; FISH OIL; ICOSAPENTAENOIC ACID; INTERLEUKIN 6; INTERLEUKIN 8; LEUKOTRIENE B4; MONOCYTE CHEMOTACTIC PROTEIN 1; OMEGA 3 FATTY ACID; PLACEBO; SURFACTANT PROTEIN D; UNCLASSIFIED DRUG; VON WILLEBRAND FACTOR;

ACUTE LUNG INJURY; ADULT; AGED; ARTICLE; ARTIFICIAL VENTILATION; CONTROLLED STUDY; HUMAN; HUMAN EXPERIMENT; LUNG LAVAGE; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; POLYMORPHONUCLEAR CELL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE;

EID: 79959671819     PISSN: 00903493     EISSN: 15300293     Source Type: Journal    
DOI: 10.1097/CCM.0b013e318218669d     Document Type: Article

References (57)

1. Rubenfeld GD, Caldwell E, Peabody E, et al: Incidence and outcomes of acute lung injury. N Engl J Med 2005; 353:1685-1693 (Pubitemid 41464707)
2. Stapleton RD, Wang BM, Hudson LD, et al: Causes and timing of death in patients with ARDS. Chest 2005; 128:525-532 (Pubitemid 41140476)
3. Mancuso P, Whelan J, DeMichele SJ, et al: Dietary fish oil and fish and borage oil suppress intrapulmonary proinflammatory eicosanoid biosynthesis and attenuate pulmonary neutrophil accumulation in endotoxic rats. Crit Care Med 1997; 25:1198-1206 (Pubitemid 27310262)
4. Palombo JD, DeMichele SJ, Boyce PJ, et al: Metabolism of dietary alpha-linolenic acid vs eicosapentaenoic acid in rat immune cell phospholipids during endotoxemia. Lipids 1998; 33:1099-1105 (Pubitemid 28559982)
5. Palombo JD, DeMichele SJ, Boyce PJ, et al: Effect of short-term enteral feeding with eicosapentaenoic and gamma-linolenic acids on alveolar macrophage eicosanoid synthesis and bactericidal function in rats. Crit Care Med 1999; 27:1908-1915 (Pubitemid 29455123)
6. Gadek JE, DeMichele SJ, Karlstad MD, et al: 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; 27:1409-1420 (Pubitemid 29406926)
7. Singer P, Theilla M, Fisher H, et al: Benefit of an enteral diet enriched with eicosapentaenoic acid and gamma-linolenic acid in ventilated patients with acute lung injury. Crit Care Med 2006; 34:1033-1038
8. Pontes-Arruda A, Aragao AM, Albuquerque JD: Effects of enteral feeding with eicosapentaenoic acid, gamma-linolenic acid, and antioxidants in mechanically ventilated patients with severe sepsis and septic shock. Crit Care Med 2006; 34:2325-2333 (Pubitemid 44260016)
9. Ware LB, Matthay MA: The acute respiratory distress syndrome. N Engl J Med 2000; 342: 1334-1349 (Pubitemid 30408719)
10. Palombo JD, Lydon EE, Chen PL, et al: Fatty acid composition of lung, macrophage and surfactant phospholipids after short-term enteral feeding with n-3 lipids. Lipids 1994; 29:643-649 (Pubitemid 24282373)
11. Yaqoob P, Pala HS, Cortina-Borja M, et al: Encapsulated fish oil enriched in alphatocopherol alters plasma phospholipid and mononuclear cell fatty acid compositions but not mononuclear cell functions. Eur J Clin Invest 2000; 30:260-274 (Pubitemid 30153668)
12. Tilley SL, Coffman TM, Koller BH: Mixed messages: Modulation of inflammation and immune responses by prostaglandins and thromboxanes. J Clin Invest 2001; 108:15-23 (Pubitemid 32634916)
13. Bulger EM, Maier RV: Lipid mediators in the pathophysiology of critical illness. Crit Care Med 2000; 28:N27-N36 (Pubitemid 30262045)
14. Lewis RA, Austen KF, Soberman RJ: Leukotrienes and other products of the 5-lipoxygenase pathway. Biochemistry and relation to pathobiology in human diseases. N Engl J Med 1990; 323:645-655 (Pubitemid 20280195)
15. Calder PC: Polyunsaturated fatty acids, inflammation, and immunity. Lipids 2001; 36: 1007-1024 (Pubitemid 33065203)
16. Obata T, Nagakura T, Masaki T, et al: Eicosapentaenoic acid inhibits prostaglandin D2generation by inhibiting cyclo-oxygenase-2 in cultured human mast cells. Clin Exp Allergy 1999; 29:1129-1135 (Pubitemid 29359432)
17. Lee TH, Menica-Huerta JM, Shih C, et al: Characterization and biologic properties of 5,12-dihydroxy derivatives of eicosapentaenoic acid, including leukotriene B5 and the double lipoxygenase product. J Biol Chem 1984; 259:2383-2389 (Pubitemid 14190356)
18. Goldman DW, Pickett WC, Goetzl EJ: Human neutrophil chemotactic and degranulating activities of leukotriene B5 (LTB5) derived from eicosapentaenoic acid. Biochem Biophys Res Commun 1983; 117:282-288 (Pubitemid 14216878)
19. Serhan CN, Savill J: Resolution of inflammation: The beginning programs the end. Nat Immunol 2005; 6:1191-1197 (Pubitemid 43045627)
20. Singer P, Shapiro H, Theilla M, et al: Antiinflammatory properties of omega-3 fatty acids in critical illness: Novel mechanisms and an integrative perspective. Intensive Care Med 2008; 34:1580-1592
21. Palombo JD, DeMichele SJ, Lydon EE, et al: Rapid modulation of lung and liver macrophage phospholipid fatty acids in endotoxemic rats by continuous enteral feeding with n-3 and gamma-linolenic fatty acids. Am J Clin Nutr 1996; 63:208-219
22. Mancuso P, Whelan J, DeMichele SJ, et al: Effects of eicosapentaenoic and gammalinolenic acid on lung permeability and alveolar macrophage eicosanoid synthesis in endotoxic rats. Crit Care Med 1997; 25:523-532 (Pubitemid 27152750)
23. Moran V, Grau T, Lorenzo AD, et al: Effect of an enteral feeding with eicosapentaenoic and gamma-linoleic acids on the outcome of mechanically ventilated critically ill septic patients. Abstr. Crit Care Med 2006; 34:A70
24. Miller A, Ziad S: Efficacy of enteral nutrition with EPA, GLA and antioxidants in patients with ARDS and MODS: A prospective multicenter randomized controlled trial. Available at: http://www.criticalcarenutrition.com/ docs/cpg/4.1bfish%20oils-FINAL.pdf. Accessed October 1, 2010
25. Canadian Critical Care Nutrition Clinical Practice Guidelines 4.1. Composition of enteral nutrition: fish oils. Available at: http://www. criticalcarenutrition.com/docs/cpg/4.1bfish%20oils-FINAL.pdf. Accessed October 1, 2010
26. Heyland DK, Schroter-Noppe D, Drover JW, et al: Nutrition support in the critical care setting: Current practice in Canadian ICUs- Opportunities for improvement? JPEN J Parenter Enteral Nutr 2003; 27:74-83 (Pubitemid 36105648)
27. Bernard GR, Artigas A, Brigham KL, et al: The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med 1994; 149: 818-824 (Pubitemid 24082248)
28. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network. N Engl J Med 2000; 342: 1301-1308
29. Goodman RB, Pugin J, Lee JS, et al: Cytokine- mediated inflammation in acute lung injury. Cytokine Growth Factor Rev 2003; 14:523-535 (Pubitemid 37296025)
30. Ranieri VM, Suter PM, Tortorella C, et al: Effect of mechanical ventilation on inflammatory mediators in patients with acute respiratory distress syndrome: A randomized controlled trial. JAMA 1999; 282:54-61 (Pubitemid 29318933)
31. Bhatia M, Moochhala S: Role of inflammatory mediators in the pathophysiology of acute respiratory distress syndrome. J Pathol 2004; 202:145-156 (Pubitemid 38208651)
32. Martin TR, Pistorese BP, Chi EY, et al: Effects of leukotriene B4 in the human lung. Recruitment of neutrophils into the alveolar spaces without a change in protein permeability. J Clin Invest 1989; 84:1609-1619 (Pubitemid 19272250)
33. Goodman RB, Strieter RM, Martin DP, et al: Inflammatory cytokines in patients with persistence of the acute respiratory distress syndrome. Am J Respir Crit Care Med 1996; 154:602-611 (Pubitemid 26327279)
34. Ware LB, Matthay MA, Parsons PE, et al: Pathogenetic and prognostic significance of altered coagulation and fibrinolysis in acute lung injury/acute respiratory distress syndrome. Crit Care Med 2007; 35:1821-1828 (Pubitemid 47220354)
35. Ware LB, Eisner MD, Thompson BT, et al: Significance of von Willebrand factor in septic and nonseptic patients with acute lung injury. Am J Respir Crit Care Med 2004; 170:766-772 (Pubitemid 39298992)
36. Eisner MD, Parsons P, Matthay MA, et al: Plasma surfactant protein levels and clinical outcomes in patients with acute lung injury. Thorax 2003; 58:983-988 (Pubitemid 37392811)
37. Calfee CS, Eisner MD, Ware LB, et al: Trauma- associated lung injury differs clinically and biologically from acute lung injury due to other clinical disorders. Crit Care Med 2007; 35:2243-2250 (Pubitemid 47476219)
38. Ware LB, Conner ER, Matthay MA: von Willebrand factor antigen is an independent marker of poor outcome in patients with early acute lung injury. Crit Care Med 2001; 29:2325-2331 (Pubitemid 34038167)
39. Marshall JC, Cook DJ, Christou NV, et al: Multiple organ dysfunction score: A reliable descriptor of a complex clinical outcome. Crit Care Med 1995; 23:1638-1652
40. Schoenfeld DA, Bernard GR: Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome. Crit Care Med 2002; 30:1772-1777 (Pubitemid 34879589)
41. Haegens A, Barrett TF, Gell J, et al: Airway epithelial NF-kappaB activation modulates asbestos-induced inflammation and mucin production in vivo. J Immunol 2007; 178: 1800-1808 (Pubitemid 46154652)
42. Debley JS, Hallstrand TS, Monge T, et al: Methods to improve measurement of cysteinyl leukotrienes in exhaled breath condensate from subjects with asthma and healthy controls. J Allergy Clin Immunol 2007; 120: 1216-1217 (Pubitemid 350029887)
43. Folch J, Lees M, Sloane Stanley GH: A simple method for the isolation and purification of total lipides from animal tissues. J Biol Chem 1957; 226:497-509
44. Schlierf G, Wood P: Quantitative determination of plasma free fatty acids and triglycerides by thin-layer chromatography. J Lipid Res 1965; 6:317-319
45. Lepage G, Roy CC: Direct transesterification of all classes of lipids in a one-step reaction. J Lipid Res 1986; 27:114-120 (Pubitemid 16045295)
46. Knaus WA, Draper EA, Wagner DP, et al: APACHE II: A severity of disease classification system. Crit Care Med 1985; 13: 818-829 (Pubitemid 15250137)
47. Murray JF, Matthay MA, Luce JM, et al: An expanded definition of the adult respiratory distress syndrome. Am Rev Respir Dis 1988; 138:720-723
48. Wheeler AP, Bernard GR, Thompson BT, et al: Pulmonary-artery versus central venous catheter to guide treatment of acute lung injury. N Engl J Med 2006; 354:2213-2224 (Pubitemid 43788136)
49. Park WY, Goodman RB, Steinberg KP, et al: Cytokine balance in the lungs of patients with acute respiratory distress syndrome. Am J Respir Crit Care Med 2001; 164: 1896-1903 (Pubitemid 33152327)
50. Pacht ER, DeMichele SJ, Nelson JL, et al: Enteral nutrition with eicosapentaenoic acid, gamma-linolenic acid, and antioxidants reduces alveolar inflammatory mediators and protein influx in patients with acute respiratory distress syndrome. Crit Care Med 2003; 31:491-500 (Pubitemid 36232946)
51. Phua J, Badia JR, Adhikari NK, et al: Has mortality from acute respiratory distress syndrome decreased over time? A systematic review. Am J Respir Crit Care Med 2009; 179: 220-227
52. Erickson SE, Martin GS, Davis JL, et al: Recent trends in acute lung injury mortality: 1996 -2005. Crit Care Med 2009; 37: 1574-1579
53. Hudson LD: New therapies for ARDS. Chest 1995; 108:79S-91S
54. Rivers E, Nguyen B, Havstad S, et al: Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001; 345:1368-1377
55. Cook DJ, Reeve BK, Guyatt GH, et al: Stress ulcer prophylaxis in critically ill patients. Resolving discordant meta-analyses. JAMA 1996; 275:308-314
56. Parsons PE, Eisner MD, Thompson BT, et al: Lower tidal volume ventilation and plasma cytokine markers of inflammation in patients with acute lung injury. Crit Care Med 2005; 33:1- 6; discussion 230-232 (Pubitemid 40116529)
57. The NHLBI ARDS Network: Trial of omega-3 fatty acid, gamma-linolenic acid and antioxidant supplementation in the management of acute lung injury (OMEGA). Results presented at the American Thoracic Society International Conference; May, 18, 2009; San Diego, CA