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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

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Perkins, Gavin D., Gates, Simon, Lamb, S. E. (Sallie E.), McCabe, Chris (Christopher J.), 1967-, Young, Duncan S. and Smith, F. Gao (Fang Gao). (2011) 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, Vol.12 (No.1). p. 113. ISSN 1745-6215

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Official URL: http://dx.doi.org/10.1186/1745-6215-12-113

Abstract

Background: The Acute Respiratory Distress Syndrome (ARDS) is a common cause of respiratory failure in critically ill patients. Experimental studies suggest that treatment with beta agonists may be helpful in ARDS. The Beta Agonist Lung Injury TrIal (BALTI-2) is a multicentre, pragmatic, randomised, double-blind, placebo-controlled clinical trial which aims to determine if sustained treatment with intravenous (IV) salbutamol will improve survival in ARDS. Methods/Design: Patients fulfilling the American-European Consensus Conference Definition of ARDS will be randomised in a 1: 1 ratio to receive an IV infusion either of salbutamol (15 mu g kg ideal body weight(-1) hr(-1)) or placebo (0.9% sodium chloride solution), for a maximum of seven days. Allocation to randomised groups will use minimisation to ensure balance with respect to hospital of recruitment, age group (<64, 65-84, >85 years) and PaO(2)/FiO(2) ratio (<= 6.7, 6.8- 13.2, >= 13.3 kPa). Data will be recorded by participating ICUs until hospital discharge, and all surviving patients will be followed up by post at six and twelve months post randomisation. The primary outcome is mortality at 28 days after randomisation; secondary outcomes are mortality in ICU, mortality in hospital, number of ventilator-free days, number of organ failure-free days, mortality at twelve months post-randomisation, quality of life at six and twelve months, length of stay in ICU, length of stay in hospital, adverse effects (tachycardia, arrhythmia or other side effects sufficient to stop treatment drug). 1,334 patients will be recruited from about fifty ICUs in the UK. An economic evaluation will be conducted alongside the trial.

Item Type:	Journal Article
Subjects:	R Medicine > RC Internal medicine
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Respiratory distress syndrome, Adult -- Treatment, Adrenergic beta agonists, Clinical trials
Journal or Publication Title:	Trials
Publisher:	Biomed Central
ISSN:	1745-6215
Date:	9 May 2011
Volume:	Vol.12
Number:	No.1
Page Range:	p. 113
Identification Number:	10.1186/1745-6215-12-113
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	Medical Research Council (Great Britain) (MRC), Intensive Care Society (Great Britain) (ICS), National Institute for Health Research (Great Britain) (NIHR)
References:	1. Ware LB, Matthay MA: The acute respiratory distress syndrome. N Engl J Med 2000, 342(18):1334-1349. 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. 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. 5. Intensive Care National Audit Research Centre: Incidence and outcome of acute respiratory failure - ICNARC data on file. 2005. 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. 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. 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. 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. 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. 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. 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. 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. 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.
URI:	http://wrap.warwick.ac.uk/id/eprint/39995