Recombinant surfactant protein C-based surfactant for patients with severe direct lung injury

American Journal of Respiratory and Critical Care Medicine

Volumn 183, Issue 8, 2011, Pages 1055-1061

  Spragg, Roger G ^a,i   Taut, Friedemann J H ^b   Lewis, James F ^c   Schenk, Peter ^d   Ruppert, Clemens ^e   Dean, Nathan ^f   Krell, Kenneth ^g   Karabinis, Andreas ^h   Günther, Andreas ^e  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Nycomed GmbH   (Germany)

^c UNIVERSITY OF WESTERN ONTARIO   (Canada)

^d MEDICAL UNIVERSITY OF VIENNA   (Austria)

^e JUSTUS LIEBIG UNIVERSITY   (Germany)

^f UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^g Eastern Idaho Medical Center   (United States)

^h KAT HOSPITAL   (Greece)

ⁱ VA SAN DIEGO HEALTHCARE SYSTEM   (United States)

Author keywords

Acute lung injury; Adult; Clinical trial; Respiratory distress syndrome

Indexed keywords

RECOMBINANT PROTEIN; SURFACTANT PROTEIN C;

ACID ASPIRATION; ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; AIRWAY OBSTRUCTION; APACHE; ARTICLE; ASSISTED VENTILATION; CARBON DIOXIDE TENSION; COMMUNITY ACQUIRED PNEUMONIA; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG WITHDRAWAL; FEMALE; HOSPITAL INFECTION; HOSPITALIZATION; HUMAN; HYPOXEMIA; INTENSIVE CARE; INTUBATION; LUNG GAS EXCHANGE; LUNG INJURY; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; MULTIPLE ORGAN FAILURE; OXYGEN TENSION; OXYGENATION; PARTICLE RESUSPENSION; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; PULMONARY ASPIRATION; RANDOMIZED CONTROLLED TRIAL; THORAX RADIOGRAPHY; TREATMENT FAILURE; TREATMENT WITHDRAWAL;

ACUTE LUNG INJURY; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CHILD; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PULMONARY GAS EXCHANGE; PULMONARY SURFACTANT-ASSOCIATED PROTEIN C; RECOMBINANT PROTEINS; RESPIRATION, ARTIFICIAL; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 79954596013     PISSN: 1073449X     EISSN: 15354970     Source Type: Journal    
DOI: 10.1164/rccm.201009-1424OC     Document Type: Article

References (28)

1. Goss CH, Brower RG, Hudson LD, Rubenfeld GD. Incidence of acute lung injury in the United States. Crit Care Med 2003;31:1607-1611. (Pubitemid 36714211)
2. Spragg RG, Lewis JF. Surfactant therapy in the acute respiratory distress syndrome. In: Acute respiratory distress syndrome. Choi A, editor. New York, NY: Informa Healthcare USA, Inc.; 2010. pp. 287-312.
3. Günther A, Walmrath D, Grimminger F, Seeger W. Surfactant metabolism and replacement in ARDS. In: European Respiratory Monograph Vol. 7, Monograph 20: Acute respiratory distress syndrome. Evans TW, Griffiths MJD, Keogh BF, editors. Sheffield, UK: European Respiratory Society; 2002. pp. 119-128.
4. Willson DF, Thomas NJ, Markovitz BP, Bauman LA, DiCarlo JV, Pon S, Jacobs BR, Jefferson LS, Conaway MR, Egan EA. Effect of exogenous surfactant (calfactant) in pediatric acute lung injury: a randomized controlled trial. JAMA 2005;293:470-476.
5. Davidson WJ, Dorscheid D, Spragg R, Schulzer M, Mak E, Ayas NT. Exogenous pulmonary surfactant for the treatment of adult patients with acute respiratory distress syndrome: results of a meta-analysis. Crit Care 2006;10:R41-R50.
6. Taut FJ, Rippin G, Schenk P, Findlay G, Wurst W, Hafner D, Lewis JF, Seeger W, Gunther A, Spragg RG. A Search for subgroups of patients with ARDS who may benefit from surfactant replacement therapy: a pooled analysis of five studies with recombinant surfactant protein-C surfactant (Venticute). Chest 2008;134:724-732.
7. The Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 2000;342:1301-1308.
8. Gregory TJ, Steinberg KP, Spragg R, Gadek JE, Hyers TM, Longmore WJ, Moxley MA, Cai GZ, Hite RD, Smith RM, et al.. Bovine surfactant therapy for patients with acute respiratory distress syndrome. Am J Respir Crit Care Med 1997;155:1309-1315. (Pubitemid 27172776)
9. Spragg RG, Gilliard N, Richman P, Smith RM, Hite RD, Pappert D, Robertson B, Curstedt T, Strayer D. Acute effects of a single dose of porcine surfactant on patients with the adult respiratory distress syndrome. Chest 1994;105:195-202. (Pubitemid 24029101)
10. Moller JC, Schaible T, Roll C, Schiffmann JH, Bindl L, Schrod L, Reiss I, Kohl M, Demirakca S, Hentschel R, et al. Treatment with bovine surfactant in severe acute respiratory distress syndrome in children: a randomized multicenter study. Intensive Care Med 2003;29:437-446. (Pubitemid 36379447)
11. Willson DF, Jiao JH, Bauman LA, Zaritsky A, Craft H, Dockery K, Conrad D, Dalton H. Calf's lung surfactant extract in acute hypoxemic respiratory failure in children. Crit Care Med 1996;24:1316-1322. (Pubitemid 26262404)
12. Willson DF, Zaritsky A, Bauman LA, Dockery K, James RL, Conrad D, Craft H, Novotny WE, Egan EA, Dalton H. Instillation of calf lung surfactant extract (calfactant) is beneficial in pediatric acute hypoxemic respiratory failure. Members of the Mid-Atlantic Pediatric Critical Care Network. Crit Care Med 1999;27:188-195. (Pubitemid 29052836)
13. Spragg RG, Lewis JF, Wurst W, Hafner D, Baughman RP, Wewers MD, Marsh JJ. Treatment of acute respiratory distress syndrome with recombinant surfactant protein C surfactant. Am J Respir Crit Care Med 2003;167:1562-1566. (Pubitemid 37363368)
14. Spragg RG, Lewis JF, Walmrath H-D, Johannigman J, Bellingan G, Laterre PF, Witte MC, Richards GA, Rippin G, Rathgeb F, et al. Effect of recombinant surfactant protein-C based surfactant on the acute respiratory distress syndrome. N Engl J Med 2004;351:884-892.
15. Weg JG, Balk RA, Tharratt RS, Jenkinson SG, Shah JB, Zaccardelli D, Horton J, Pattishall EN. Safety and potential efficacy of an aerosolized surfactant in human sepsis-induced adult respiratory distress syndrome. JAMA 1994;272:1433-1438. (Pubitemid 24328386)
16. Anzueto A, Baughman R, Guntupalli KK, Weg JG, Wiedemann HP, Raventos AA, Lemaire F, Long W, Zaccardelli DS, Pattishall EN. Aerosolized surfactants in adults with sepsis-induced acute respiratory distress syndrome. N Engl J Med 1996;334:1417-1421. (Pubitemid 26157436)
17. Kesecioglu J, Beale R, Stewart TE, Findlay GP, Rouby JJ, Holzapfel L, Bruins P, Steenken EJ, Jeppesen OK, Lachmann B. Exogenous natural surfactant for treatment of acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med 2009;180:989-994.
18. Häfner D, Germann PG, Hauschke D. Comparison of rSP-C surfactant with natural and synthetic surfactants after late treatment in a rat model of the acute respiratory distress syndrome. Br J Pharmacol 1998;124:1083-1090. (Pubitemid 28333929)
19. Spragg RG, Smith RM, Harris K, Lewis J, Häfner D, Germann. P. Effect of recombinant SP-C surfactant in a porcine lavage model of acute lung injury. J Appl Physiol 2000;88:674-681. (Pubitemid 30097113)
20. Davis AJ, Jobe AH, Häfner D, Ikegami M. Lung function in premature lambs and rabbits treated with a recombinant SP-C surfactant. Am J Respir Crit Care Med 1998;157:553-559. (Pubitemid 28090549)
21. Spragg RG, Masys DR, Sergeant D, Lawrie T, Taut FJ. An informatics strategy to assure enrollment criteria compliance in studies of the critically ill. Contemp Clin Trials 2010;31:530-535.
22. Fishman GS, Moore LR. A statistical evaluation of multiplicative congruential random number generators with modulus 231-1. J Am Stat Assoc 1982;77:129-136.
23. Häfner D, Beume R, Kilian U, Krasznai G, Lachmann B. Dose-response comparisons of five lung surfactant factor (LSF) preparations in an animal model of adult respiratory distress syndrome (ARDS). Br J Pharmacol 1995;115:451-458.
24. Markart P, Ruppert C, Wygrecka M, Colaris T, Dahal B, Walmrath D, Harbach H, Wilhelm J, Seeger W, Schmidt R, et al. Patients with ARDS show improvement but not normalisation of alveolar surface activity with surfactant treatment: putative role of neutral lipids. Thorax 2007;62:588-594. (Pubitemid 47056885)
25. Markart P, Ruppert C, Grimminger F, Seeger W, GüntherA. Fibrinolysisinhibitory capacity of clot-embedded surfactant is enhanced by SP-B and SP-C. Am J Physiol Lung Cell Mol Physiol 2003;284:L69-L76. (Pubitemid 35471259)
26. Murray JF, Matthay MA, Luce JM, Flick MR. An expanded definition of the adult respiratory distress syndrome. Am Rev Respir Dis 1988;138:720-723.
27. [Published erratum appears in Am Rev Respir Dis 139: 1065.]
28. Spragg RG, Bernard GR, Checkley W, Curtis JR, Gajic O, Guyatt G, Hall J, Israel E, Jain M, Needham DM, et al. Beyond mortality: future clinical research in acute lung injury. Am J Respir Crit Care Med 2010;181:1121-1127.