Relationship Between Plasma Metabolome and the Efficacy of Systemic Glucocorticoid in AECOPD

NCT04710849 | Unknown

• 1 other identifier: PUTH-COPD001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) significantly increases the mortality of the patients with COPD. Guidelines have recommended systemic glucocorticoid as regular treatment. Recently, evidences have shown that systemic glucocorticoid cannot not be 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.

Conditions

COPD; COPD Exacerbation Acute

Outcome Measures

Primary Outcomes (1)

• Metabolic markers related to systemic glucocorticoid therapy

  Through metabolomics research methods such as liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry, study the metabolic marker group profile of patients with acute exacerbation of COPD before receiving systemic glucocorticoid therapy, and look for possible systemic metabolic markers related to the short-term and long-term effects of glucocorticoids.

  1 year

Secondary Outcomes (8)

• Length of hospital stay

  1 year

• Time from discharge to the next exacerbation

  1 year

• Side effects of glucocorticoid therapy

  1 year

• Mortality within 1 year

  1 year

• Acute exacerbation frequency

  1 year

Study Arms (2)

Treatment Failure Group

The diagnostic criteria of AECOPD is defined in global initiative for chronic obstructive lung disease (GOLD 2016). According to the efficacy of systemic hormone therapy during hospitalization, they were divided into treatment success group and treatment failure group. Definition of systemic glucocorticoid treatment failure during hospitalization is (Reference: Crisafulli E, Torres A, Huerta A, et al. COPD, 2016, 13(1): 82-92): The following occurs from the 2nd to the 7th day after admission Situation: ①Need to receive mechanical ventilation treatment or need to be admitted to the ICU due to illness; ②72 hours after the initial anti-infective treatment, clinical signs of infection persist and need to change antibiotic treatment; ③Death from any cause.

Diagnostic Test: Serum metabolic markers

Treatment Success Group

The diagnostic criteria of AECOPD is defined in global initiative for chronic obstructive lung disease (GOLD 2016). According to the efficacy of systemic hormone therapy during hospitalization, they were divided into treatment success group and treatment failure group. The treatment success group was defined as not meeting any of the following conditions for failure of systemic hormone therapy during hospitalization (reference: Crisafulli E, Torres A, Huerta A, et al. COPD, 2016, 13(1): 82-92): ①Need to receive mechanical ventilation treatment or need to be admitted to the ICU due to illness; ②72 hours after the initial anti-infective treatment, clinical signs of infection persist and need to change antibiotic treatment; ③Death from any cause.

Diagnostic Test: Serum metabolic markers

Interventions

Serum metabolic markers DIAGNOSTIC_TEST

Ultraperformance liquid chromatography / mass spectrometry (LC-MS) and gas chromatography / mass spectrometry (GC-MS) methods for analysis of the metabolites in AECOPD patients and compare the metabolites profiles between patients with systemic glucocorticoid treatment success and treatment failure.

Also known as: Metbolomics

Treatment Failure Group; Treatment Success Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A prospective study was conducted to recruit consecutive patients from January 1, 2020 to January 1, 2021 who were hospitalized in the Department of Respiratory and Critical Care Medicine in Peking University Third Hospital and met the diagnostic criteria of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in Global Initiative for Chronic Obstructive Lung Diseas 2016 (GOLD 2016).

You may qualify if:

• Patients who meet the diagnostic criteria for acute exacerbation of chronic obstructive pulmonary disease in GOLD 2016 and require hospitalization.

You may not qualify if:

• Bronchial asthma, bronchiectasis and other airflow obstructive diseases;
• Combined with community-acquired pneumonia, hospital-acquired pneumonia or aspiration pneumonia;
• Combined with severe liver and kidney insufficiency;
• Malignant tumor;
• Immune deficiency due to chemotherapy or HIV infection;
• Received systemic hormone therapy due to acute exacerbation of chronic obstructive pulmonary disease within 1 month before this admission;
• Severe trauma or stress, etc.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

Related Publications (1)

• Li QY, An ZY, Pan ZH, Qi RY. 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. BMC Pulm Med. 2021 Jul 28;21(1):250. doi: 10.1186/s12890-021-01614-3.

  PMID: 34320980 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor of Department of Respiratory and Critical Care Medicine

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 15, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

CN (1)