The adult calfactant in acute respiratory distress syndrome trial

Chest

Volumn 148, Issue 2, 2015, Pages 356-364

  Willson, Douglas F ^a   Truwit, Jonathon D ^b   Conaway, Mark R ^c   Traul, Christine S ^d   Egan, Edmund E ^e,f  

^a VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b MEDICAL COLLEGE OF WISCONSIN   (United States)

^c UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

^d LERNER RESEARCH INSTITUTE   (United States)

^e Pneuma Pharmaceuticals   (United States)

^f UNIVERSITY AT BUFFALO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALFACTANT; OXYGEN; PLACEBO; BIOLOGICAL PRODUCT; LUNG SURFACTANT;

ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; ARTERIAL OXYGEN TENSION; ARTICLE; ARTIFICIAL VENTILATION; ATRIAL FIBRILLATION; BRONCHOSPASM; CONTROLLED STUDY; DRUG WITHDRAWAL; FEMALE; HEART ARREST; HUMAN; HYPOTENSION; HYPOXIA; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; OXYGENATION; PATIENT COMPLIANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; SURVIVAL RATE; TIDAL VOLUME; TREATMENT OUTCOME; AGED; ANOXIA; CHEMICALLY INDUCED; CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; EARLY TERMINATION OF CLINICAL TRIAL; MIDDLE AGED; OXIMETRY; RESPIRATORY DISTRESS SYNDROME, ADULT;

ADULT; AGED; ANOXIA; BIOLOGICAL PRODUCTS; DOUBLE-BLIND METHOD; EARLY TERMINATION OF CLINICAL TRIALS; FEMALE; HUMANS; HYPOTENSION; LENGTH OF STAY; MALE; MIDDLE AGED; OXIMETRY; PULMONARY SURFACTANTS; RESPIRATION, ARTIFICIAL; RESPIRATORY DISTRESS SYNDROME, ADULT; TREATMENT OUTCOME;

EID: 84939228194     PISSN: 00123692     EISSN: 19313543     Source Type: Journal    
DOI: 10.1378/chest.14-1139     Document Type: Article

References (67)

1. 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 (18): 1301-1308.
2. Gregory TJ, Longmore WJ, Moxley MA, et al. Surfactant chemical composition and biophysical activity in acute respiratory distress syndrome. J Clin Invest. 1991; 88 (6): 1976-1981.
3. Günther A, Siebert C, Schmidt R, et al. Surfactant alterations in severe pneumonia, acute respiratory distress syndrome, and cardiogenic lung edema. Am J Respir Crit Care Med. 1996; 153 (1): 176-184.
4. Holm BA, Enhorning G, Notter RH. A biophysical mechanism by which plasma proteins inhibit lung surfactant activity. Chem Phys Lipids. 1988; 49 (1-2): 49-55.
5. Holm BA, Notter RH. Effects of hemoglobin and cell membrane lipids on pulmonary surfactant activity. J Appl Physiol (1985). 1987; 63 (4): 1434-1442.
6. Holm BA, Notter RH, Finkelstein JN. Surface property changes from interactions of albumin with natural lung surfactant and extracted lung lipids. Chem Phys Lipids. 1985; 38 (3): 287-298.
7. Holm BA, Wang Z, Notter RH. Multiple mechanisms of lung surfactant inhibition . Pediatr Res. 1999; 46 (1): 85-93.
8. Lewis JF, Ikegami M, Jobe AH. Altered surfactant function and metabolism in rabbits with acute lung injury. J Appl Physiol (1985). 1990; 69 (6): 2303-2310.
9. Pison U, Seeger W, Buchhorn R, et al. Surfactant abnormalities in patients with respiratory failure aft er multiple trauma. Am Rev Respir Dis. 1989; 140 (4): 1033-1039.
10. Seeger W, Pison U, Buchhorn R, Obertacke U, Joka T. Surfactant abnormalities and adult respiratory failure. Lung. 1990; 168 (suppl): 891-902.
11. Seeger W, Stöhr G, Wolf HR, Neuhof H. Alteration of surfactant function due to protein leakage: special interaction with fibrin monomer. J Appl Physiol (1985). 1985; 58 (2): 326-338.
12. Veldhuizen RA, McCaig LA, Akino T, Lewis JF. Pulmonary surfactant subfractions in patients with the acute respiratory distress syndrome. Am J Respir Crit Care Med. 1995; 152 (6 pt 1): 1867-1871.
13. Seeger W, Grube C, Günther A, Schmidt R. Surfactant inhibition by plasma proteins: differential sensitivity of various surfactant preparations. Eur Respir J. 1993; 6 (7): 971-977.
14. Günther A, Schmidt R, Harodt J, et al. Bronchoscopic administration of bovine natural surfactant in ARDS and septic shock: impact on biophysical and biochemical surfactant properties. Eur Respir J. 2002; 19 (5): 797-804.
15. Spragg RG, Gilliard N, Richman P, et al. Acute effects of a single dose of porcine surfactant on patients with the adult respiratory distress syndrome. Chest. 1994; 105 (1): 195-202.
16. Walmrath D, Grimminger F, Pappert D, et al. Bronchoscopic administration of bovine natural surfactant in ARDS and septic shock: impact on gas exchange and haemodynamics. Eur Respir J. 2002; 19 (5): 805-810.
17. Walmrath D, Günther A, Ghofrani HA, et al. Bronchoscopic surfactant administration in patients with severe adult respiratory distress syndrome and sepsis. Am J Respir Crit Care Med. 1996; 154 (1): 57-62.
18. Wiswell TE, Smith RM, Katz LB, et al. Bronchopulmonary segmental lavage with Surfaxin (KL(4)-surfactant) for acute respiratory distress syndrome. Am J Respir Crit Care Med. 1999; 160 (4): 1188-1195.
19. Anzueto A, Baughman RP, Guntupalli KK, et al; Exosurf Acute Respiratory Distress Syndrome Sepsis Study Group. Aerosolized surfactant in adults with sepsis-induced acute respiratory distress syndrome. N Engl J Med. 1996; 334 (22): 1417-1421.
20. Gregory TJ, Steinberg KP, Spragg R, et al. Bovine surfactant therapy for patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 1997; 155 (4): 1309-1315.
21. Kesecioglu J, Beale R, Stewart TE, et al. Exogenous natural surfactant for treatment of acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2009; 180 (10): 989-994.
22. Spragg RG, Lewis JF, Walmrath H-D, et al. Effect of recombinant surfactant protein C-based surfactant on the acute respiratory distress syndrome. N Engl J Med. 2004; 351 (9): 884-892.
23. Spragg RG, Taut FJH, Lewis JF, et al. Recombinant surfactant protein C-based surfactant for patients with severe direct lung injury. Am J Respir Crit Care Med. 2011; 183 (8): 1055-1061.
24. Hermon MM, Golej J, Burda G, et al. Surfactant therapy in infants and children: three years experience in a pediatric intensive care unit. Shock. 2002; 17 (4): 247-251.
25. Herting E, Möller O, Schiffmann JH, Robertson B. Surfactant improves oxygenation in infants and children with pneumonia and acute respiratory distress syndrome. Acta Paediatr. 2002; 91 (11): 1174-1178.
26. López-Herce J, de Lucas N, Carrillo A, Bustinza A, Moral R. Surfactant treatment for acute respiratory distress syndrome. Arch Dis Child. 1999; 80 (3): 248-252.
27. Luchetti M, Casiraghi G, Valsecchi R, Galassini E, Marraro G. Porcine-derived surfactant treatment of severe bronchiolitis . Acta Anaesthesiol Scand. 1998; 42 (7): 805-810.
28. Luchetti M, Ferrero F, Gallini C, et al. Multicenter, randomized, controlled study of porcine surfactant in severe respiratory syncytial virus-induced respiratory failure. Pediatr Crit Care Med. 2002; 3 (3): 261-268.
29. Möller JC, Schaible T, Roll C, et al; Surfactant ARDS Study Group. Treatment with bovine surfactant in severe acute respiratory distress syndrome in children: a randomized multicenter study. Intensive Care Med. 2003; 29 (3): 437-446.
30. Willson DF, Jiao JH, Bauman LA, et al. Calf 's lung surfactant extract in acute hypoxemic respiratory failure in children. Crit Care Med. 1996; 24 (8): 1316-1322.
31. Willson DF, Thomas NJ, Markovitz BP, et al; Pediatric Acute Lung Injury and Sepsis Investigators. Effect of exogenous surfactant (calfactant) in pediatric acute lung injury: a randomized controlled trial. JAMA. 2005; 293 (4): 470-476.
32. Willson DF, Zaritsky A, Bauman LA, et al; Members of the Mid-Atlantic Pediatric Critical Care Network. Instillation of calf lung surfactant extract (calfactant) is beneficial in pediatric acute hypoxemic respiratory failure. Crit Care Med. 1999; 27 (1): 188-195.
33. Auten RL, Notter RH, Kendig JW, Davis JM, Shapiro DL. Surfactant treatment of full-term newborns with respiratory failure. Pediatrics. 1991; 87 (1): 101-107.
34. Findlay RD, Taeusch HW, Walther FJ. Surfactant replacement therapy for meconium aspiration syndrome. Pediatrics. 1996; 97 (1): 48-52.
35. Khammash H, Perlman M, Wojtulewicz J, Dunn M. Surfactant therapy in full-term neonates with severe respiratory failure. Pediatrics. 1993; 92 (1): 135-139.
36. Lotze A, Knight GR, Martin GR, et al. Improved pulmonary outcome aft er exogenous surfactant therapy for respiratory failure in term infants requiring extracorporeal membrane oxygenation. J Pediatr. 1993; 122 (2): 261-268.
37. Lotze A, Mitchell BR, Bulas DI, Zola EM, Shalwitz RA, Gunkel JH; Survanta in Term Infants Study Group. Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure. J Pediatr. 1998; 132 (1): 40-47.
38. Clark JC, Wert SE, Bachurski CJ, et al. Targeted disruption of the surfactant protein B gene disrupts surfactant homeostasis, causing respiratory failure in newborn mice. Proc Natl Acad Sci USA. 1995; 92 (17): 7794-7798.
39. Ikegami M, Whitsett JA, Martis PC, Weaver TE. Reversibility of lung inflammation caused by SP-B deficiency. Am J Physiol Lung Cell Mol Physiol. 2005; 289 (6): L962-L970.
40. Mizuno K, Ikegami M, Chen CM, Ueda T, Jobe AH. Surfactant protein-B supplementation improves in vivo function of a modified natural surfactant. Pediatr Res. 1995; 37 (3): 271-276.
41. Oosterlaken-Dijksterhuis MA, van Eijk M, van Golde LM, Haagsman HP. Lipid mixing is mediated by the hydrophobic surfactant protein SP-B but not by SP-C. Biochim Biophys Acta. 1992; 1110 (1): 45-50.
42. Revak SD, Merritt TA, Degryse E, et al. Use of human surfactant low molecular weight apoproteins in the reconstitution of surfactant biologic activity. J Clin Invest. 1988; 81 (3): 826-833.
43. Seeger W, Günther A, Thede C. Differential sensitivity to fibrinogen inhibition of SP-C-vs. SP-B-based surfactants. Am J Physiol. 1992; 262 (3 pt 1): L286-L291.
44. Wang Z, Baatz JE, Holm BA, Notter RH. Content-dependent activity of lung surfactant protein B in mixtures with lipids. Am J Physiol Lung Cell Mol Physiol. 2002; 283 (5): L897-L906.
45. Wang Z, Gurel O, Baatz JE, Notter RH. Differential activity and lack of synergy of lung surfactant proteins SP-B and SP-C in interactions with phospholipids. J Lipid Res. 1996; 37 (8): 1749-1760.
46. Willson DF, Thomas NJ, Tamburro R, et al; Pediatric Acute Lung and Sepsis Investigators Network. Pediatric calfactant in acute respiratory distress syndrome trial. Pediatr Crit Care Med. 2013; 14 (7): 657-665.
47. O'Brien PC, Flemming TR. A multiple testing procedure for clinical trials. Biometrics. 1979; 35: 153-162.
48. Brower RG, Lanken PN, MacIntyre N, et al; National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med. 2004; 351 (4): 327-336.
49. National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, et al. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012; 307 (8): 795-803.
50. Steinberg KP, Hudson LD, Goodman RB, et al; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Efficacy and safety of corticosteroids for persistent acute respiratory distress syndrome. N Engl J Med. 2006; 354 (16): 1671-1684.
51. National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, et al. Comparison of two fluidmanagement strategies in acute lung injury. N Engl J Med. 2006; 354 (24): 2564-2575.
52. Ferguson ND, Kacmarek RM, Chiche JD, et al. Screening of ARDS patients using standardized ventilator settings: influence on enrollment in a clinical trial. Intensive Care Med. 2004; 30 (6): 1111-1116.
53. Villar J, Pérez-Méndez L, López J, et al; HELP Network. An early PEEP/FIO2 trial identifies different degrees of lung injury in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007; 176 (8): 795-804.
54. ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, et al. Acute respiratory distress syndrome: the Berlin Definition. J AMA. 2012; 307 (23): 2526-2533.
55. Briel M, Meade M, Mercat A, et al. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and metaanalysis . J AMA. 2010; 303 (9): 865-873.
56. Herm J, Fiebach JB, Koch L, et al. Neuropsychological effects of MRI-detected brain lesions aft er left atrial catheter ablation for atrial fibrillation: long-term results of the MACPAF study. Circ Arrhythm Electrophysiol. 2013; 6 (5): 843-850.
57. Lu S, Cai S, Ou C, Zhao H. Establishment and evaluation of a simplified evaluation system of acute respiratory distress syndrome . Y onsei Med J. 2013; 54 (4): 935-941.
58. Brower RG, Morris A, MacIntyre N, et al; ARDS Clinical Trials Network, National Heart, Lung, and Blood Institute, National Institutes of Health. Effects of recruitment maneuvers in patients with acute lung injury and acute respiratory distress syndrome ventilated with high positive end-expiratory pressure [published correction appears in Crit Care Med. 2004;32(3):907]. C rit Care Med. 2003; 31 (11): 2592-2597.
59. Fan E, Wilcox ME, Brower RG, et al. Recruitment maneuvers for acute lung injury: a systematic review. Am J Respir Crit Care Med. 2008; 178 (11): 1156-1163.
60. Gattinoni L, Caironi P, Cressoni M, et al. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006; 354 (17): 1775-1786.
61. Lu Q, Zhang M, Girardi C, Bouhemad B, Kesecioglu J, Rouby JJ. Computed tomography assessment of exogenous surfactant-induced lung reaeration in patients with acute lung injury. Crit Care. 2010; 14 (4): R135.
62. Willson DF, Thomas NJ, Tamburro R, et al. The relationship of fluid administration to outcome in the Pediatric Calfactant in Acute Respiratory Distress Syndrome (CARDS) Trial. Pediatr Crit Care Med. 2013; 14 (7): 666-672.
63. Sibbald WJ, Short AK, Warshawski FJ, Cunningham DG, Cheung H. Thermal dye measurements of extravascular lung water in critically ill patients. Intravascular Starling forces and extravascular lung water in the adult respiratory distress syndrome. Chest. 1985; 87 (5): 585-592.
64. Ware LB, Matthay MA. The acute respiratory distress syndrome. N Engl J Med. 2000; 342 (18): 1334-1349.
65. Notter RH. L ung Surfactants: Basic Science and Clinical Applications. New York, NY: Marcel Dekker Inc; 2000.
66. Wang ZHB, Matalon S, Notter RH. L ung Injury: Mechanisms, Pathophysiology, and Therapy. Boca Raton, FL: Taylor Francis Group, Inc; 2005: 297-352.
67. Rubenfeld GD, Caldwell E, Peabody E, et al. Incidence and outcomes of acute lung injury. N Engl J Med. 2005; 353 (16): 1685-1693.