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The beta agonist lung injury trial prevention. A randomized controlled trial
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Perkins, Gavin D., Gates, Simon, Park, Daniel P., Smith, F. Gao (Fang Gao), Knox, Christopher R., Holloway, Ben, McAuley, Daniel F., Ryan, James, Marzouk, Joseph, Cooke, Matthew W., Lamb, S. E. (Sallie E.) and Thickett, David R. (2014) The beta agonist lung injury trial prevention. A randomized controlled trial. American Journal of Respiratory and Critical Care Medicine, Volume 189 (Number 6). pp. 674-683. doi:10.1164/rccm.201308-1549OC ISSN 1073-449X.
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Official URL: http://dx.doi.org/10.1164/rccm.201308-1549OC
Abstract
Rationale: Experimental studies suggest that pretreatment with β-agonists might prevent acute lung injury (ALI).
Objectives: To determine if in adult patients undergoing elective esophagectomy, perioperative treatment with inhaled β-agonists effects the development of early ALI.
Methods: We conducted a randomized placebo-controlled trial in 12 UK centers (2008–2011). Adult patients undergoing elective esophagectomy were allocated to prerandomized, sequentially numbered treatment packs containing inhaled salmeterol (100 μg twice daily) or a matching placebo. Patients, clinicians, and researchers were masked to treatment allocation. The primary outcome was development of ALI within 72 hours of surgery. Secondary outcomes were ALI within 28 days, organ failure, adverse events, survival, and health-related quality of life. An exploratory substudy measured biomarkers of alveolar-capillary inflammation and injury.
Measurements and Main Results: A total of 179 patients were randomized to salmeterol and 183 to placebo. Baseline characteristics were similar. Treatment with salmeterol did not prevent early lung injury (32 [19.2%] of 168 vs. 27 [16.0%] of 170; odds ratio [OR], 1.25; 95% confidence interval [CI], 0.71–2.22). There was no difference in organ failure, survival, or health-related quality of life. Adverse events were less frequent in the salmeterol group (55 vs. 70; OR, 0.63; 95% CI, 0.39–0.99), predominantly because of a lower number of pneumonia (7 vs. 17; OR, 0.39; 95% CI, 0.16–0.96). Salmeterol reduced some biomarkers of alveolar inflammation and epithelial injury.
Conclusion: Perioperative treatment with inhaled salmeterol was well tolerated but did not prevent ALI.
Item Type: | Journal Article | ||||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | American Journal of Respiratory and Critical Care Medicine | ||||||||
Publisher: | American Thoracic Society | ||||||||
ISSN: | 1073-449X | ||||||||
Official Date: | 15 March 2014 | ||||||||
Dates: |
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Volume: | Volume 189 | ||||||||
Number: | Number 6 | ||||||||
Page Range: | pp. 674-683 | ||||||||
DOI: | 10.1164/rccm.201308-1549OC | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Restricted or Subscription Access | ||||||||
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