Beta Agonist Lung Injury TrIal-2 (BALTI-2) trial protocol: A randomised, double-blind, placebo-controlled of intravenous infusion of salbutamol in the acute respiratory distress syndrome

Trials

Volumn 12, Issue , 2011, Pages

  Perkins, Gavin D ^a,b   Gates, Simon ^a   Lamb, Sarah E ^a   McCabe, Chris ^c   Young, Duncan ^d   Gao, Fang ^a,b  

^a UNIVERSITY OF WARWICK   (United Kingdom)

^b UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST   (United Kingdom)

^c UNIVERSITY OF LEEDS   (United Kingdom)

^d JOHN RADCLIFFE HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; SALBUTAMOL SULFATE; SODIUM CHLORIDE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; SALBUTAMOL;

ADOLESCENT; ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; AGED; ARTICLE; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DOUBLE BLIND PROCEDURE; FEMALE; FOLLOW UP; HEART ARRHYTHMIA; HOSPITALIZATION; HUMAN; INTENSIVE CARE UNIT; LENGTH OF STAY; LUNG VENTILATION; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; OUTCOME ASSESSMENT; OXYGEN TENSION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SURVIVAL; TACHYCARDIA; UNITED KINGDOM; ARTIFICIAL VENTILATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; COST BENEFIT ANALYSIS; DRUG COST; ECONOMICS; HOSPITAL COST; INTRAVENOUS DRUG ADMINISTRATION; METHODOLOGY; PLACEBO EFFECT; SURVIVAL RATE; TIME; TREATMENT OUTCOME;

ADRENERGIC BETA-2 RECEPTOR AGONISTS; ALBUTEROL; COST-BENEFIT ANALYSIS; DOUBLE-BLIND METHOD; DRUG COSTS; FEMALE; GREAT BRITAIN; HOSPITAL COSTS; HOSPITAL MORTALITY; HUMANS; INFUSIONS, INTRAVENOUS; INTENSIVE CARE UNITS; LENGTH OF STAY; MALE; PLACEBO EFFECT; RESEARCH DESIGN; RESPIRATION, ARTIFICIAL; RESPIRATORY DISTRESS SYNDROME, ADULT; SURVIVAL RATE; TIME FACTORS; TREATMENT OUTCOME;

EID: 79955694326     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-12-113     Document Type: Article

References (19)

1. Ware LB, Matthay MA. The acute respiratory distress syndrome. N Engl J Med 2000, 342(18):1334-1349. 10.1056/NEJM200005043421806, 10793167.
2. 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(3 Pt 1):818-824.
3. Brun-Buisson C, Minelli C, Bertolini G, Brazzi L, Pimentel J, Lewandowski K, Bion J, Romand JA, Villar J, Thorsteinsson A, et al. Epidemiology and outcome of acute lung injury in European intensive care units. Results from the ALIVE study. Intensive Care Med 2004, 30(1):51-61. 10.1007/s00134-003-2022-6, 14569423.
4. Hughes M, MacKirdy FN, Ross J, Norrie J, Grant IS. Acute respiratory distress syndrome: an audit of incidence and outcome in Scottish intensive care units. Anaesthesia 2003, 58(9):838-845. 10.1046/j.1365-2044.2003.03287.x, 12911354.
5. Intensive Care National Audit Research Centre Incidence and outcome of acute respiratory failure - ICNARC data on file. 2005, Intensive Care National Audit Research Centre.
6. Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, et al. One-year outcomes in survivors of the acute respiratory distress syndrome. NEnglJ Med 2003, 348(8):683-693.
7. Dowdy DW, Eid MP, Dennison CR, Mendez-Tellez PA, Herridge MS, Guallar E, Pronovost PJ, Needham DM. Quality of life after acute respiratory distress syndrome: a meta-analysis. Intensive Care Med 2006, 32(8):1115-1124. 10.1007/s00134-006-0217-3, 16783553.
8. Adhikari N, Burns KE, Meade MO. Pharmacologic therapies for adults with acute lung injury and acute respiratory distress syndrome. CochraneDatabaseSystRev 2004, (4):CD004477.
9. Perkins GD, McAuley DF, Richter A, Thickett DR, Gao F. Bench-to-bedside review: beta2-Agonists and the acute respiratory distress syndrome. Crit Care 2004, 8(1):25-32. 10.1186/cc2417, 420065, 14975042.
10. Perkins GD, Nathani N, McAuley DF, Gao F, Thickett DR. In vitro and in vivo effects of salbutamol on neutrophil function in acute lung injury. Thorax 2007, 62(1):36-42. 10.1136/thx.2006.059410, 2111273, 16928710.
11. Maris NA, de Vos AF, Dessing MC, Spek CA, Lutter R, Jansen HM, van der Zee JS, Bresser P, van der Poll T. Antiinflammatory Effects of Salmeterol after Inhalation of Lipopolysaccharide by Healthy Volunteers. American Journal of Respiratory and Critical Care Medicine 2005, 172(7):878-884. 10.1164/rccm.200503-451OC, 15994467.
12. McAuley DF, Frank JA, Fang X, Matthay MA. Clinically relevant concentrations of beta2-adrenergic agonists stimulate maximal cyclic adenosine monophosphate-dependent airspace fluid clearance and decrease pulmonary edema in experimental acid-induced lung injury. Crit Care Med 2004, 32(7):1470-1476. 10.1097/01.CCM.0000129489.34416.0E, 15241090.
13. Perkins GD, Gao F, Thickett DR. In vivo and in vitro effects of salbutamol on alveolar epithelial repair in acute lung injury. Thorax 2008, 63(3):215-220. 10.1136/thx.2007.080382, 17951278.
14. Matthay MA, Flori HR, Conner ER, Ware LB. Alveolar epithelial fluid transport: basic mechanisms and clinical relevance. ProcAssocAmPhysicians 1998, 110(6):496-505.
15. O'Kane CM, McKeown SW, Perkins GD, Bassford CR, Gao F, Thickett DR, McAuley DF. Salbutamol up-regulates matrix metalloproteinase-9 in the alveolar space in the acute respiratory distress syndrome. Crit Care Med 2009, 37(7):2242-2249. 10.1097/CCM.0b013e3181a5506c, 19487934.
16. Perkins GD, McAuley DF, Thickett DR, Gao F. The beta-agonist lung injury trial (BALTI): a randomized placebo-controlled clinical trial. AmJRespirCrit Care Med 2006, 173(3):281-287.
17. Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials 2010, 11:32. 10.1186/1745-6215-11-32, 2857832, 20334632.
18. Assessment of Low tidal Volume and elevated End-expiratory volume to Obviate Lung Injury (ALVEOLI): Trial protocol. , http://www.ardsnet.org/system/files/alveoli_protocol_and_amendments_0.pdf
19. Felton T, Sander R, Al-Aloul M, Dark P, Bentley A. Can a score derived from the Critical Care Minimum Data Set be used as a marker of organ dysfunction? - a pilot study. BMC Research Notes 2009, 2(1):77. 10.1186/1756-0500-2-77, 2688517, 19419551.