Effect of a selective neutrophil elastase inhibitor on mortality and ventilator-free days in patients with increased extravascular lung water: A post hoc analysis of the PiCCO Pulmonary Edema Study

Journal of Intensive Care

Volumn 2, Issue 1, 2014, Pages

  Tagami, Takashi ^a,b   Tosa, Ryoichi ^c   Omura, Mariko ^c   Fukushima, Hidetada ^d   Kaneko, Tadashi ^e   Endo, Tomoyuki ^f   Rinka, Hiroshi ^g   Murai, Akira ^h   Yamaguchi, Junko ⁱ   Yoshikawa, Kazuhide ^j   Saito, Nobuyuki ^k   Uzu, Hideaki ^l   Kase, Yoichi ^m   Takatori, Makoto ⁿ   Izumino, Hiroo ^o   Nakamura, Toshiaki ^p   Seo, Ryutarou ^q   Kitazawa, Yasuhide ^r   Sugita, Manabu ^s   Takahashi, Hiroyuki ^t   Kuroki, Yuichi ^u   Irahara, Takayuki ^v   Kanemura, Takashi ^w   Yokota, Hiroyuki ^a   Kushimoto, Shigeki ^x   more..

^a NIPPON MEDICAL SCHOOL   (Japan)

^b UNIVERSITY OF TOKYO   (Japan)

^c Central Aizu General Hospital   (Japan)

^d NARA MEDICAL UNIVERSITY   (Japan)

^e YAMAGUCHI UNIVERSITY HOSPITAL   (Japan)

^f TOHOKU UNIVERSITY HOSPITAL   (Japan)

^g OSAKA CITY GENERAL HOSPITAL   (Japan)

^h FUKUOKA UNIVERSITY   (Japan)

ⁱ NIHON UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^j TOKYO MEDICAL AND DENTAL UNIVERSITY HOSPITAL   (Japan)

^k NIPPON MEDICAL SCHOOL CHIBA HOKUSOH HOSPITAL   (Japan)

^l KURUME UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^m JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

ⁿ HIROSHIMA CITY HOSPITAL   (Japan)

^o KANSAI MEDICAL UNIVERSITY MEDICAL CENTER   (Japan)

^p NAGASAKI UNIVERSITY HOSPITAL   (Japan)

^q KOBE CITY MEDICAL CENTER GENERAL HOSPITAL   (Japan)

^r KANSAI MEDICAL UNIVERSITY   (Japan)

^s JUNTENDO UNIVERSITY NERIMA HOSPITAL   (Japan)

^t SAISEIKAI YOKOHAMASHI TOBU HOSPITAL   (Japan)

^u CHUKYO HOSPITAL   (Japan)

^v NIPPON MEDICAL SCHOOL TAMA NAGAYAMA HOSPITAL   (Japan)

^w NATIONAL HOSPITAL ORGANIZATION DISASTER MEDICAL CENTER   (Japan)

^x TOHOKU UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

more..

Author keywords

Acute lung injury; Extravascular lung water; Pulmonary edema; Pulmonary vascular permeability index; Transpulmonary thermodilution technique

Indexed keywords

SIVELESTAT;

ADULT RESPIRATORY DISTRESS SYNDROME; AGED; APACHE; ARTICLE; ARTIFICIAL VENTILATION; COHORT ANALYSIS; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; ECHOCARDIOGRAPHY; FEMALE; HUMAN; INTENSIVE CARE UNIT; LUNG EDEMA; LUNG EXTRAVASCULAR FLUID; MAJOR CLINICAL STUDY; MALE; MEDICAL PARAMETERS; MORTALITY; MULTICENTER STUDY; POST HOC ANALYSIS; PRIORITY JOURNAL; PROSPECTIVE STUDY; SEQUENTIAL ORGAN FAILURE ASSESSMENT SCORE; VENTILATOR FREE DAYS;

EID: 84979195063     PISSN: None     EISSN: 20520492     Source Type: Journal    
DOI: 10.1186/s40560-014-0067-y     Document Type: Article

References (58)

1. Fujishima S. Pathophysiology and biomarkers of acute respiratory distress syndrome. J Intensive Care 2014, 2:32. 10.1186/2052-0492-2-32, 25520844.
2. Koh Y. Update in acute respiratory distress syndrome. J Intensive Care 2014, 2:2. 10.1186/2052-0492-2-2, 25520820.
3. Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin definition. JAMA 2012, 307:2526-2533. 22797452.
4. Zeiher BG, Matsuoka S, Kawabata K, Repine JE. Neutrophil elastase and acute lung injury: prospects for sivelestat and other neutrophil elastase inhibitors as therapeutics. Crit Care Med 2002, 30:S281-S287. 10.1097/00003246-200205001-00018, 12004249.
5. Donnelly SC, MacGregor I, Zamani A, Gordon MW, Robertson CE, Steedman DJ, Little K, Haslett C. Plasma elastase levels and the development of the adult respiratory distress syndrome. Am J Respir Crit Care Med 1995, 151:1428-1433. 10.1164/ajrccm.151.5.7735596, 7735596.
6. Iba T, Kidokoro A, Fukunaga M, Takuhiro K, Yoshikawa S, Sugimotoa K. Pretreatment of sivelestat sodium hydrate improves the lung microcirculation and alveolar damage in lipopolysaccharide-induced acute lung inflammation in hamsters. Shock 2006, 26:95-98. 10.1097/01.shk.0000223126.34017.d9, 16783204.
7. Tamakuma N, Shiba T, Hirasawa H, Ogawa M, Nakashima S. A phase III clinical study of neutrophil elastase inhibitor ONO-5046*Na in SIRS patients. J Clin Ther Med (Jpn) 1998, 14:289-318.
8. Zeiher BG, Artigas A, Vincent J-L, Dmitrienko A, Jackson K, Thompson BT, Bernard G. Neutrophil elastase inhibition in acute lung injury: results of the STRIVE study. Crit Care Med 2004, 32:1695-1702. 10.1097/01.CCM.0000133332.48386.85, 15286546.
9. Tamakuma S, Ogawa M, Aikawa N, Kubota T, Hirasawa H, Ishizaka A, Taenaka N, Hamada C, Matsuoka S, Abiru T. Relationship between neutrophil elastase and acute lung injury in humans. Pulm Pharmacol Ther 2004, 17:271-279. 10.1016/j.pupt.2004.05.003, 15477122.
10. Aikawa N, Ishizaka A, Hirasawa H, Shimazaki S, Yamamoto Y, Sugimoto H, Shinozaki M, Taenaka N, Endo S, Ikeda T, Kawasaki Y. Reevaluation of the efficacy and safety of the neutrophil elastase inhibitor, Sivelestat, for the treatment of acute lung injury associated with systemic inflammatory response syndrome; a phase IV study. Pulm Pharmacol Ther 2011, 24:549-554. 10.1016/j.pupt.2011.03.001, 21540122.
11. Iwata K, Doi A, Ohji G, Oka H, Oba Y, Takimoto K, Igarashi W, Gremillion DH, Shimada T. Effect of neutrophil elastase inhibitor (sivelestat sodium) in the treatment of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS): a systematic review and meta-analysis. Intern Med 2010, 49:2423-2432. 10.2169/internalmedicine.49.4010, 21088343.
12. Oda S, Aibiki M, Ikeda T, Imaizumi H, Endo S, Ochiai R, Kotani J, Shime N, Nishida O, Noguchi T, Matuda N, Hirasawa H. The Japanese guidelines for the management of sepsis. J Intensive Care 2014, 2:55. 10.1186/s40560-014-0055-2.
13. Corrin B, Nicholson A. Pathology of the Lungs 2011, Churchill Livingstone, Edinburgh.
14. Tagami T, Kushimoto S, Yokota H: Quantitative evaluation of pulmonary edema. In Annual Update in Intensive Care and Emergency Medicine 2014. Edited by Vincent J-L. Springer International Publishing; 2014: 257-267. [Vincent J-L (Series Editor)].
15. Jozwiak M, Silva S, Persichini R, Anguel N, Osman D, Richard C, Teboul JL, Monnet X. Extravascular lung water is an independent prognostic factor in patients with acute respiratory distress syndrome. Crit Care Med 2013, 41:472-480. 10.1097/CCM.0b013e31826ab377, 23263578.
16. Kushimoto S, Endo T, Yamanouchi S, Sakamoto T, Ishikura H, Kitazawa Y, Taira Y, Okuchi K, Tagami T, Watanabe A, Yamaguchi J, Yoshikawa K, Sugita M, Kase Y, Kanemura T, Takahashi H, Kuroki Y, Izumino H, Rinka H, Seo R, Takatori M, Kaneko T, Nakamura T, Irahara T, Saito N. Relationship between extravascular lung water and severity categories of acute respiratory distress syndrome by the Berlin definition. Crit Care 2013, 17:R132. 10.1186/cc12811, 23844662.
17. Tagami T, Nakamura T, Kushimoto S, Tosa R, Watanabe A, Kaneko T, Fukushima H, Rinka H, Kudo D, Uzu H, Murai A, Takatori M, Izumino H, Kase Y, Seo R, Takahashi H, Kitazawa Y, Yamaguchi J, Sugita M, Takahashi H, Kuroki Y, Kanemura T, Morisawa K, Saito N, Irahara T, Yokota H. Early-phase changes of extravascular lung water index as a prognostic indicator in acute respiratory distress syndrome patients. Ann Intens Care 2014, 4:27. 10.1186/s13613-014-0027-7.
18. Tagami T, Sawabe M, Kushimoto S, Marik PE, Mieno MN, Kawaguchi T, Kusakabe T, Tosa R, Yokota H, Fukuda Y. Quantitative diagnosis of diffuse alveolar damage using extravascular lung water. Crit Care Med 2013, 41:2144-2150. 10.1097/CCM.0b013e31828a4643, 23760152.
19. Kushimoto S, Taira Y, Kitazawa Y, Okuchi K, Sakamoto T, Ishikura H, Endo T, Yamanouchi S, Tagami T, Yamaguchi J, Yoshikawa K, Sugita M, Kase Y, Kanemura T, Takahashi H, Kuroki Y, Izumino H, Rinka H, Seo R, Takatori M, Kaneko T, Nakamura T, Irahara T, Saito N, Watanabe A. The clinical usefulness of extravascular lung water and pulmonary vascular permeability index to diagnose and characterize pulmonary edema: a prospective multicenter study on the quantitative differential diagnostic definition for acute lung injury/acute respiratory distress syndrome. Crit Care 2012, 16:R232. 10.1186/cc11898, 23232188.
20. Endo T, Kushimoto S, Yamanouchi S, Sakamoto T, Ishikura H, Kitazawa Y, Taira Y, Okuchi K, Tagami T, Watanabe A, Yamaguchi J, Yoshikawa K, Sugita M, Kase Y, Kanemura T, Takahashi H, Kuroki Y, Izumino H, Rinka H, Seo R, Takatori M, Kaneko T, Nakamura T, Irahara T, Saito N. Limitations of global end-diastolic volume index as a parameter of cardiac preload in the early phase of severe sepsis: a subgroup analysis of a multicenter, prospective observational study. J Intens Care 2013, 1:11. 10.1186/2052-0492-1-11.
21. Kaneko T, Kawamura Y, Maekawa T, Tagami T, Nakamura T, Saito N, Kitazawa Y, Ishikura H, Sugita M, Okuchi K, Rinka H, Watanabe A, Kase Y, Kushimoto S, Izumino H, Kanemura T, Yoshikawa K, Takahashi H, Irahara T, Sakamoto T, Kuroki Y, Taira Y, Seo R, Yamaguchi J, Takatori M. Global end-diastolic volume is an important contributor to increased extravascular lung water in patients with acute lung injury and acuterespiratory distress syndrome: a multicenter observational study. J Intens Care 2014, 2:25. 10.1186/2052-0492-2-25.
22. Morisawa K, Fujitani S, Taira Y, Kushimoto S, Kitazawa Y, Okuchi K, Ishikura H, Sakamoto T, Tagami T, Yamaguchi J, Sugita M, Kase Y, Kanemura T, Takahashi H, Kuroki Y, Izumino H, Rinka H, Seo R, Takatori M, Kaneko T, Nakamura T, Irahara T, Saitou N, Watanabe A. Difference in pulmonary permeability between indirect and direct acute respiratory distress syndrome assessed by the transpulmonary thermodilution technique: a prospective, observational, multi-institutional study. J Intens Care 2014, 2:24. 10.1186/2052-0492-2-24.
23. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med 1985, 13:818-829. 10.1097/00003246-198510000-00009, 3928249.
24. Ferreira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA 2001, 286:1754-1758. 10.1001/jama.286.14.1754, 11594901.
25. Monnet X, Anguel N, Osman D, Hamzaoui O, Richard C, Teboul JL. Assessing pulmonary permeability by transpulmonary thermodilution allows differentiation of hydrostatic pulmonary edema from ALI/ARDS. Intens Care Med 2007, 33:448-453. 10.1007/s00134-006-0498-6.
26. Tagami T, Kushimoto S, Tosa R, Omura M, Yonezawa K, Akiyama G, Hirama H, Yokota H. Plasma neutrophil elastase correlates with pulmonary vascular permeability: a prospective observational study in patients with pneumonia. Respirology 2011, 16:953-958. 10.1111/j.1440-1843.2011.01997.x, 21605276.
27. Tagami T, Kushimoto S, Yamamoto Y, Atsumi T, Tosa R, Matsuda K, Oyama R, Kawaguchi T, Masuno T, Hirama H, Yokota H. Validation of extravascular lung water measurement by single transpulmonary thermodilution: human autopsy study. Crit Care 2010, 14:R162. 10.1186/cc9250, 20819213.
28. Craig TR, Duffy MJ, Shyamsundar M, McDowell C, McLaughlin B, Elborn JS, McAuley DF. Extravascular lung water indexed to predicted body weight is a novel predictor of intensive care unit mortality in patients with acute lung injury. Crit Care Med 2010, 38:114-120. 10.1097/CCM.0b013e3181b43050, 19789451.
29. Phillips CR, Chesnutt MS, Smith SM. Extravascular lung water in sepsis-associated acute respiratory distress syndrome: indexing with predicted body weight improves correlation with severity of illness and survival. Crit Care Med 2008, 36:69-73. 10.1097/01.CCM.0000295314.01232.BE, 18090369.
30. 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. 10.1097/00003246-200208000-00016, 12163791.
31. Austin PC. The use of propensity score methods with survival or time-to-event outcomes: reporting measures of effect similar to those used in randomized experiments. Stat Med 2014, 33:1242-1258. 10.1002/sim.5984, 24122911.
32. Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivar Behav Res 2011, 46:399-424. 10.1080/00273171.2011.568786.
33. Mikkelsen ME, Shah CV, Meyer NJ, Gaieski DF, Lyon S, Miltiades AN, Goyal M, Fuchs BD, Bellamy SL, Christie JD. The epidemiology of acute respiratory distress syndrome in patients presenting to the emergency department with severe sepsis. Shock 2013, 40:375-381. 10.1097/SHK.0b013e3182a64682, 23903852.
34. Lin C-Y, Kao K-C, Tian Y-C, Jenq C-C, Chang M-Y, Chen Y-C, Fang J-T, Huang C-C, Tsai Y-H, Yang C-W. Outcome scoring systems for acute respiratory distress syndrome. Shock 2010, 34:352-357. 10.1097/SHK.0b013e3181d8e61d, 20844411.
35. Hayashida K, Fujishima S, Sasao K, Orita T, Toyoda Y, Kitano M, Hori S. Early administration of sivelestat, the neutrophil elastase inhibitor, in adults for acute lung injury following gastric aspiration. Shock 2011, 36:223-227. 10.1097/SHK.0b013e318225acc3, 21617577.
36. Hayakawa M, Katabami K, Wada T, Sugano M, Hoshino H, Sawamura A, Gando S. Sivelestat (selective neutrophil elastase inhibitor) improves the mortality rate of sepsis associated with both acute respiratory distress syndrome and disseminated intravascular coagulation patients. Shock 2010, 33:14-18. 10.1097/SHK.0b013e3181aa95c4, 19487982.
37. Hashimoto S, Okayama Y, Shime N, Kimura A, Funakoshi Y, Kawabata K, Ishizaka A, Amaya F. Neutrophil elastase activity in acute lung injury and respiratory distress syndrome. Respirology 2008, 13:581-584. 10.1111/j.1440-1843.2008.01283.x, 18410258.
38. Endo S, Sato N, Yaegashi Y, Suzuki Y, Kojika M, Yamada Y, Yoshida Y, Nakadate T, Aoki H, Inoue Y. Sivelestat sodium hydrate improves septic acute lung injury by reducing alveolar dysfunction. Res Commun Mol Pathol Pharmacol 2006, 119:53-65. 17974096.
39. Takeda S, Ishizaka A, Fujino Y, Fukuoka T, Nagano O, Yamada Y, Takezawa J. Time to change diagnostic criteria of ARDS: toward the disease entity-based subgrouping. Pulm Pharmacol Ther 2005, 18:115-119. 10.1016/j.pupt.2004.11.001, 15712404.
40. Iwata K. The propensity score analysis on the efficacy of sivelestat. Pulm Pharmacol Ther 2013, 26:395. 10.1016/j.pupt.2012.11.002, 23219888.
41. Aikawa N. The propensity score analysis on the efficacy of Sivelestat - author's reply. Pulm Pharmacol Ther 2013, 26:396-397. 10.1016/j.pupt.2013.02.005, 23428647.
42. Rinka H, Yoshimoto A, Matsuura Y, Miyaichi T, Kan A, Kaji A, Miyanmoto S. Neutrophil elastase inhibitor improves the vascular permeability in patients with sepsis induced ALI/ARDS. Nihon Kyukyu Igakukai Zasshi 2007, 7:283-290. (Japanese), 10.3893/jjaam.18.283.
43. Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med 2005, 353:1685-1693. 10.1056/NEJMoa050333, 16236739.
44. Cruz DN, Antonelli M, Fumagalli R, Foltran F, Brienza N, Donati A, Malcangi V, Petrini F, Volta G, Bobbio Pallavicini FM, Rottoli F, Giunta F, Ronco C. Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA 2009, 301:2445-2452. 10.1001/jama.2009.856, 19531784.
45. Lee SK, Son BS, Hwang JJ, Kim KD, Kim DH. The use of neutrophil elastase inhibitor in the treatment of acute lung injury after pneumonectomy. J Cardiothorac Surg 2013, 8:69. 10.1186/1749-8090-8-69, 23566653.
46. Tagami T, Matsui H, Horiguchi H, Fushimi K, Yasunaga H: Low-dose corticosteroid use and mortality in severe community-acquired pneumonia patients. Eur Resp J 2014. In Press.
47. Tsuboko Y, Takeda S, Sakamoto A, Mii S, Nakazato K, Tanaka K, Uchida E. Clinical evaluation of sivelestat for acute lung injury/acute respiratory distress syndrome following surgery for abdominal sepsis. Drug Des Devel Ther 2012, 6:273-278. 10.2147/DDDT.S36436, 23091371.
48. Miyoshi S, Hamada H, Ryoji I, Katayama H, Irifune K, Suwaki T, Nakanishi N, Kanematsu T, Kentaro D, Aibiki M, Okura T, Higaki J. Usefulness of a selective neutrophil elastase inhibitor, sivelestat, in acute lung injury patients with sepsis. Drug Des Devel Ther 2013, 7:305-316. 10.2147/DDDT.S42004, 23596346.
49. Tang BM, Craig JC, Eslick GD, Seppelt I, McLean AS. Use of corticosteroids in acute lung injury and acute respiratory distress syndrome: a systematic review and meta-analysis. Crit Care Med 2009, 37:1594-1603. 10.1097/CCM.0b013e31819fb507, 19325471.
50. Tagami T, Kuwamoto K, Watanabe A, Unemoto K, Yokobori S, Matsumoto G, Yokota H. Optimal range of global end-diastolic volume for fluid management after aneurysmal subarachnoid hemorrhage: a multicenter prospective cohort study. Crit Care Med 2014, 42:1348-1356. 10.1097/CCM.0000000000000163, 24394632.
51. Kadoi Y, Hinohara H, Kunimoto F, Saito S, Goto F, Kosaka T, Leta K. Pilot study of the effects of ONO-5046 in patients with acute respiratory distress syndrome. Anesth Analg 2004, 99:872-877. 10.1213/01.ANE.0000129996.22368.85, 15333424.
52. Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, Legall JR, Morris A, Spragg R. 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. 10.1164/ajrccm.149.3.7509706, 7509706.
53. Monnet X, Persichini R, Ktari M, Jozwiak M, Richard C, Teboul JL. Precision of the transpulmonary thermodilution measurements. Crit Care 2011, 15:R204. 10.1186/cc10421, 21871112.
54. Michard F, Fernandez-Mondejar E, Kirov MY, Malbrain M, Tagami T. A new and simple definition for acute lung injury. Crit Care Med 2012, 40:1004-1006. 10.1097/CCM.0b013e31823b97fd, 22343856.
55. Martin GS, Eaton S, Mealer M, Moss M. Extravascular lung water in patients with severe sepsis: a prospective cohort study. Crit Care 2005, 9:R74-R82. 10.1186/cc3025, 15774053.
56. Kuzkov VV, Kirov MY, Sovershaev MA, Kuklin VN, Suborov EV, Waerhaug K, Bjertnaes LJ. Extravascular lung water determined with single transpulmonary thermodilution correlates with the severity of sepsis-induced acute lung injury. Crit Care Med 2006, 34:1647-1653. 10.1097/01.CCM.0000218817.24208.2E, 16625129.
57. Letourneau JL, Pinney J, Phillips CR. Extravascular lung water predicts progression to acute lung injury in patients with increased risk. Crit Care Med 2012, 40:847-854. 10.1097/CCM.0b013e318236f60e, 22036857.
58. Suissa S. Immortal time bias in pharmaco-epidemiology. Am J Epidemiol 2008, 167:492-499. 10.1093/aje/kwm324, 18056625.