Rationale and design of REGULATE: an observational study protocol for relationship between plasma metabolome and the efficacy of systemic glucocorticoid in acute exacerbation of chronic obstructive pulmonary disease

• Published in: BMC pulmonary medicine 2021-07, Vol.21 (1), p.250-250, Article 250
• Main Authors: Li, Qiu-Yu, An, Zhuo-Yu, Pan, Zi-Han, Qi, Rui-Ying
• Format: Article
• Language: English
• Subjects: Biomarkers; Blood plasma; Chromatography; Chronic obstructive pulmonary disease; Corticosteroids; Dexamethasone; Diabetes; Discriminant analysis; Disease; Disease Progression; Dosage and administration; Drug therapy; Gas chromatography; Genetic aspects; Glucocorticoids; Glucocorticoids - administration & dosage; Glucocorticoids - pharmacology; Health aspects; Hospitals; Humans; Length of stay; Liquid chromatography; Lung diseases; Lung diseases, Obstructive; Mass spectrometry; Mass spectroscopy; Metabolic pathways; Metabolism; Metabolites; Metabolome; Metabolomics; Mortality; Observational studies; Obstructive lung disease; Patients; Physiological aspects; Plasma; Pneumonia; Principal components analysis; Prognosis; Prospective Studies; Pulmonary Disease, Chronic Obstructive - blood; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonology; Quality control; Research Design; Scientific imaging; Study Protocol; Success; Treatment Outcome; Ventilators
• ISSN: 1471-2466; 1471-2466
• DOI: 10.1186/s12890-021-01614-3

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) significantly increases the mortality of patients with COPD. Guidelines have recommended systemic glucocorticoid as a regular treatment. Recently, evidence has shown that systemic glucocorticoid cannot be a benefit to all of the patients with AECOPD. Thus, the problem that how the clinicians can screen the patients who can benefit from systemic glucocorticoid needs to be solved urgently. This study is aimed to detect the metabolic biomarkers and metabolic pathways that are related to the efficacy of systemic glucocorticoid and contribute to the precise treatment of COPD. In this study, we will utilize ultraperformance liquid chromatography/mass spectrometry (LC-MS) and gas chromatography/mass spectrometry (GC-MS) methods for the analysis of the metabolites in AECOPD patients and compare the metabolites profiles between patients with systemic glucocorticoid treatment success group and treatment failure group. We aim to detect the metabolic biomarkers and metabolic pathways that are related to the efficacy of systemic glucocorticoid and contribute to the precise treatment of COPD. Previous studies have found that plasma metabolome changed significantly after dexamethasone treatment in healthy participants. Furthermore, inter-person variability was high and remained uninfluenced by treatment, suggesting the potential of metabolomics for predicting the efficacy and side effects of systemic glucocorticoid. Therefore, we hypothesized that metabolome changes in patients with AECOPD may be associated with the efficacy of systemic glucocorticoid. Trial registration Clinicaltrials.gov registration number NCT04710849. Registered 15 January 2021, https://clinicaltrials.gov/ct2/show/NCT04710849 .