The Library

The Beta Agonist Lung Injury TrIal (BALTI) : prevention trial protocol

Tools

Perkins, Gavin D., Park, Daniel P., Alderson, Derek, Cooke, Matthew, MB ChB, Smith, F. Gao (Fang Gao), Gates, Simon, Lamb, S. E. (Sallie E.), Mistry, Dipesh and Thickett, David R.. (2011) The Beta Agonist Lung Injury TrIal (BALTI) : prevention trial protocol. Trials, Vol.12 (No.1). p. 79. ISSN 1745-6215

Preview

PDF
WRAP_Perkins0170657-lb-210711_1745-6215-12-79.pdf - Published Version - Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader
Download (329Kb)

Official URL: http://dx.doi.org/10.1186/1745-6215-12-79

Abstract

Background: Acute lung injury complicates approximately 25-30% of subjects undergoing oesophagectomy. Experimental studies suggest that treatment with beta agonists may prevent the development of acute lung injury by decreasing inflammatory cell infiltration, activation and inflammatory cytokine release, enhancing basal alveolar fluid clearance and improving alveolar capillary barrier function. Methods/Design: The Beta Agonist Lung Injury TrIal (prevention) is a multi-centre, randomised, double blind, placebo-controlled trial. The aim of the trial is to determine in patients undergoing elective transthoracic oesphagectomy, if treatment with inhaled salmeterol 100 mcg twice daily started at induction of anaesthesia and continued for 72 hours thereafter compared to placebo affect the incidence of early acute lung injury and other clinical, resource and patient focused outcomes. The primary outcome will be the development of acute lung injury within 72 hours of oesophagectomy. The trial secondary outcomes are the development of acute lung injury during the first 28 days post operatively; PaO2: FiO2 ratio; the number of ventilator and organ failure free days, 28 and 90 day survival; health related quality of life and resource utilisation. The study aims to recruit 360 patients from 10 UK centres.

Item Type:	Journal Article
Subjects:	R Medicine > RD Surgery R Medicine > RM Therapeutics. Pharmacology
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Lungs -- Wounds and injuries -- Prevention, Esophagectomy -- Complications, Adrenergic beta agonists
Journal or Publication Title:	Trials
Publisher:	BioMed Central Ltd.
ISSN:	1745-6215
Date:	15 March 2011
Volume:	Vol.12
Number:	No.1
Page Range:	p. 79
Identification Number:	10.1186/1745-6215-12-79
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	Intensive Care Society (Great Britain) (ICS), National Institute for Health Research (Great Britain) (NIHR)
References:	1. 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. 2. 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. 3. Cheung AM, Tansey CM, Tomlinson G, az-Granados N, Matte A, Barr A, Mehta S, Mazer CD, Guest CB, Stewart TE, et al: Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. AmJ RespirCrit Care Med 2006, 174(5):538-544. 4. Baudouin SV: Lung injury after thoracotomy. BrJAnaesth 2003, 91(1):132-142. 5. Park D, Goureveith D, Perkins GD: Lung injury after oesophagectomy. In Yearbook of Intensive Care and Emergency Medicine Volume 29. Edited by: Vincent JL. Germany: Springer; 2008:155-160. 6. Park D, Welch C, Harrison D, Palser T, Cromwell D, Gao F, Alderson D, Rowan K, Perkins G: Outcomes following oesophagectomy in patients with oesophageal cancer: a secondary analysis of the ICNARC Case Mix Programme Database. Critical Care 2009, 13(Suppl 2):S1. 7. McCulloch P, Ward J, Tekkis PP: Mortality and morbidity in gastrooesophageal cancer surgery: initial results of ASCOT multicentre prospective cohort study. BMJ 2003, 327(7425):1192-1197. 8. Sherry K: Management of patients undergoing oesophagectomy. In Report of the National Confidential Enquiry Into Peri-Operative Deaths. Edited by: Gray AJG, Hoile RW, Ingram GS, Sherry K. London: National CEPOD; 1997:57-61. 9. Schilling MK, Gassmann N, Sigurdsson GH, Regli B, Stoupis C, Furrer M, Signer C, Redaelli C, Buchler MW: Role of thromboxane and leukotriene B4 in patients with acute respiratory distress syndrome after oesophagectomy. BrJAnaesth 1998, 80(1):36-40. 10. Ware LB, Matthay MA: The acute respiratory distress syndrome. NEnglJMed 2000, 342(18):1334-1349. 11. 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. 12. 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. 13. 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. 14. Berthiaume Y, Matthay MA: Alveolar edema fluid clearance and acute lung injury. Respir Physiol Neurobiol 2007, 159(3):350-359. 15. 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. 16. Basran GS, Hardy JG, Woo SP, Ramasubramanian R, Byrne AJ: Beta-2- adrenoceptor agonists as inhibitors of lung vascular permeability to radiolabelled transferrin in the adult respiratory distress syndrome in man. EurJ NuclMed 1986, 12(8):381-384. 17. 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. 18. Matthay MA, Folkesson HG, Clerici C: Lung epithelial fluid transport and the resolution of pulmonary edema. Physiol Rev 2002, 82(3):569-600. 19. Sartori C, Allemann Y, Duplain H, Lepori M, Egli M, Lipp E, Hutter D, Turini P, Hugli O, Cook S, et al: Salmeterol for the prevention of high-altitude pulmonary edema. NEnglJ Med 2002, 346(21):1631-1636. 20. 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. 21. Schulz KF, Altman DG, Moher D: CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials 2010, 11:32. 22. Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, LeGall JR, Morris A, Spragg R: Report of the American-European Consensus conference on acute respiratory distress syndrome: definitions, mechanisms, relevant outcomes, and clinical trial coordination. Consensus Committee. JCrit Care 1994, 9(1):72-81. 23. : 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. 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: The Journal of the American Medical Association 2001, 286(14):1754-1758. 25. Perkins GD, Chatterjee S, Giles S, McAuley DF, Quinton S, Thickett DR, Gao F: Safety and tolerability of nonbronchoscopic lavage in ARDS. Chest 2005, 127(4):1358-1363. 26. Perkins GD, Chatterjie S, McAuley DF, Gao F, Thickett DR: Role of nonbronchoscopic lavage for investigating alveolar inflammation and permeability in acute respiratory distress syndrome. Crit Care Med 2006, 34(1):57-64. 27. Maris NA, de Vos AF, Bresser P, van der Zee JS, Jansen HM, Levi M, van der PT: Salmeterol enhances pulmonary fibrinolysis in healthy volunteers. Crit Care Med 2007, 35(1):57-63. 28. Harvey S, Harrison DA, Singer M, Ashcroft J, Jones CM, Elbourne D, Brampton W, Williams D, Young D, Rowan K: Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial. Lancet 2005, 366(9484):472-477.
URI:	http://wrap.warwick.ac.uk/id/eprint/36421