Open Access Study protocol

Vitamin D to prevent acute lung injury following oesophagectomy (VINDALOO): study protocol for a randomised placebo controlled trial

Dhruv Parekh12, Rachel C A Dancer1, Sian Lax1, Mark S Cooper1, Adrian R Martineau3, William D Fraser4, Olga Tucker1, Derek Alderson1, Gavin D Perkins2, Fang Gao-Smith1 and David R Thickett1*

Author Affiliations

1 College of Medical and Dental Sciences, University of Birmingham, Vincent Drive, Birmingham B15 2TT, UK

2 Warwick Medical School Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Warwick, Coventry CV4 7AL, UK

3 Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, St Dunstan’s Road, London E1 2AB, UK

4 Norwich Medical School, University of East Anglia, University Drive, Norwich NR4 7TJ, UK

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Trials 2013, 14:100  doi:10.1186/1745-6215-14-100

Published: 17 April 2013

Abstract

Background

Acute lung injury occurs in approximately 25% to 30% of subjects undergoing oesophagectomy. Experimental studies suggest that treatment with vitamin D may prevent the development of acute lung injury by decreasing inflammatory cytokine release, enhancing lung epithelial repair and protecting alveolar capillary barrier function.

Methods/Design

The ‘Vitamin D to prevent lung injury following oesophagectomy trial’ is a multi-centre, randomised, double-blind, placebo-controlled trial. The aim of the trial is to determine in patients undergoing elective transthoracic oesophagectomy, if pre-treatment with a single oral dose of vitamin D3 (300,000 IU (7.5 mg) cholecalciferol in oily solution administered seven days pre-operatively) compared to placebo affects biomarkers of early acute lung injury and other clinical outcomes. The primary outcome will be change in extravascular lung water index measured by PiCCO® transpulmonary thermodilution catheter at the end of the oesophagectomy. The trial secondary outcomes are clinical markers indicative of lung injury: PaO2:FiO2 ratio, oxygenation index; development of acute lung injury to day 28; duration of ventilation and organ failure; survival; safety and tolerability of vitamin D supplementation; plasma indices of endothelial and alveolar epithelial function/injury, plasma inflammatory response and plasma vitamin D status. The study aims to recruit 80 patients from three UK centres.

Discussion

This study will ascertain whether vitamin D replacement alters biomarkers of lung damage following oesophagectomy.

Trial registration

Current Controlled Trials ISRCTN27673620

Keywords:
Acute lung injury; One lung ventilation; Oesophagectomy; Vitamin D