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

Perkins, Gavin D.; Park, Daniel; Alderson, Derek; Cooke, Matthew; Gao, Fang; Gates, Simon; Lamb, Sarah E; Mistry, Dipesh; Thickett, David

doi:10.1186/1745-6215-12-79

Cited by 13 publications

(8 citation statements)

References 25 publications

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“…Proposed causative mechanisms for this injury include the ischaemic/reperfusion insult suffered by the collapsed lung, as well as oxidative stress and barotrauma causing epithelial injury to the ventilated lung [9]. These mechanisms are important in the pathogenesis of ALI making OLV a valid model for studying the pathogenesis of ALI in humans and exploring therapeutic strategies for preventing lung injury in a predefined subject population [10,11]. …”

Section: Introductionmentioning

confidence: 99%

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

Parekh

Dancer

Lax

et al. 2013

Trials

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BackgroundAcute 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/DesignThe ‘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.DiscussionThis study will ascertain whether vitamin D replacement alters biomarkers of lung damage following oesophagectomy.Trial registrationCurrent Controlled Trials ISRCTN27673620

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Section: Introductionmentioning

confidence: 99%

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

Parekh

Dancer

Lax

et al. 2013

Trials

Self Cite

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“…We have also found that i.v. b-agonists (salbutamol) reduced extravascular lung water and improved lung injury in ARDS patients (17)(18)(19). However, in a multicenter, randomized, controlled clinical trial, i.v.…”

mentioning

confidence: 99%

Resolvin D1 Stimulates Alveolar Fluid Clearance through Alveolar Epithelial Sodium Channel, Na,K-ATPase via ALX/cAMP/PI3K Pathway in Lipopolysaccharide-Induced Acute Lung Injury

Wang

Zheng

Cheng

et al. 2014

The Journal of Immunology

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Resolvin D1 (7S,8R,17S-trihydroxy-4Z,9E,11E,13Z,15E,19Z-docosahexaenoic acid) (RvD1), generated from ω-3 fatty docosahexaenoic acids, is believed to exert anti-inflammatory properties including inhibition of neutrophil activation and regulating inflammatory cytokines. In this study, we sought to investigate the effect of RvD1 in modulating alveolar fluid clearance (AFC) on LPS-induced acute lung injury. In vivo, RvD1 was injected i.v. (5 μg/kg) 8 h after LPS (20 mg/kg) administration, which markedly stimulated AFC in LPS-induced lung injury, with the outcome of decreased pulmonary edema. In addition, rat lung tissue protein was isolated after intervention and we found RvD1 improved epithelial sodium channel (ENaC) α, γ, Na,K-adenosine triphosphatase (ATPase) α1, β1 subunit protein expression and Na,K-ATPase activity. In primary rat alveolar type II epithelial cells stimulated with LPS, RvD1 not only upregulated ENaC α, γ and Na,K-ATPase α1 subunits protein expression, but also increased Na+ currents and Na,K-ATPase activity. Finally, protein kinase A and cGMP were not responsible for RvD1’s function because a protein kinase A inhibitor (H89) and cGMP inhibitor (Rp-cGMP) did not reduce RvD1’s effects. However, the RvD1 receptor (formyl-peptide receptor type 2 [FPR2], also called ALX [the lipoxin A4 receptor]) inhibitor (BOC-2), cAMP inhibitor (Rp-cAMP), and PI3K inhibitor (LY294002) not only blocked RvD1’s effects on the expression of ENaC α in vitro, but also inhibited the AFC in vivo. In summary, RvD1 stimulates AFC through a mechanism partly dependent on alveolar epithelial ENaC and Na,K-ATPase activation via the ALX/cAMP/PI3K signaling pathway.

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“…The BALTI-prevention study is a double blind placebo controlled trial investigating whether inhalation of the long acting β-agonist salmeterol can prevent the development of ALI in patients undergoing esophagectomy (ISRCTN47481946) [34]. The trial completed recruitment in June 2011 and is due to report in 2012 when follow-up is complete.…”

Section: Clinical Studies Of β-Agonists In Ardsmentioning

confidence: 99%