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

Perkins, Gavin D and Park, Daniel and Alderson, Derek and Cooke, Matthew W and Gao, Fang and Gates, Simon and Lamb, Sarah E and Mistry, Dipesh and Thickett, David R (2011) The Beta Agonist Lung Injury TrIal (BALTI)--prevention trial protocol. Trials, 12. p. 79. ISSN 1745-6215.

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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.

TRIAL REGISTRATION NUMBER

Current Controlled Trials ISRCTN47481946.

Item Type: Article
Subjects: WD Diseases and disorders of systemic, metabolic or environmental origin > WD400 Emergency medicine
WF Respiratory system. Respiratory medicine
Divisions: Emergency Services
Planned IP Care > Respiratory Medicine
Related URLs:
Depositing User: Sophie Rollason
Date Deposited: 18 Dec 2014 11:05
Last Modified: 18 Dec 2014 11:05
URI: http://www.repository.heartofengland.nhs.uk/id/eprint/800

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