Risk Stratifying COPD Exacerbations

Recruiting

• Conditions: COPD Exacerbation
• Interventions: Other: Observation only

• Registration Number: NCT05852327
• Lead Sponsor: Pamela Youde Nethersole Eastern Hospital

Brief Summary

To identify clinical characteristics on presentation which predict differential outcomes in patients with exacerbation of COPD.

Detailed Description

Exacerbations of COPD (ECOPD) are heterogenous but are often considered as a single clinical entity. Clinical characteristics on presentation may predict outcome of patients with ECOPD.

DECAF score was previously proposed to predict in-hospital mortality but has not been validated in Asian subjects. ROME classification was recently proposed to better risk stratify ECOPD according to symptoms, physiological parameters and laboratory findings on admission, but no prospective validation study is available so far.

This study aims to identify clinical characteristics on presentation to predict outcome of patients with ECOPD.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-05-01
• Study First Submitted QC: 2023-05-01
• Study First Posted: 2023-05-10
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-23
• Last Update Posted: 2023-12-27
• Primary Completion: 2024-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Background history of COPD, defined by the GOLD 2023 guidelines
• Presented with exacerbation of COPD, defined by the GOLD 2023 guidelines
• Age >= 18 years old
• Informed consent available

Exclusion Criteria

• Age < 18 years old
• No informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD	Observation only	Subjects with COPD exacerbation

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	3-month	Number of patients died during hospitalization of ECOPD
Bacterial etiology	3-month	Frequency of various bacterial etiology identified during ECOPD
3-month mortality	3-month	Number of patients died 3 months after ECOPD
Recurrent ECOPD	3-month	Number of patients with recurrent ECOPD post-discharge
Viral etiology	3-month	Frequency of various viral etiology identified during ECOPD

Trial Locations

Locations (2)

Pamela Youde Nethersole Eastern Hospital; 🇭🇰 Hong Kong, Hong Kong

Charles Wong; 🇭🇰 Hong Kong, Other, Hong Kong