COPD-ICU Multicentre Prospective Observational Register

COPD Exacerbation Acute Clinical Trial

— COPD-ICU  

Official title:

Epidemiological, Clinical and Biological Characteristics and Therapeutic Management of ICU Patients With Severe Acute Exacerbation of COPD. Evaluation of the Prognosis and the Factors Associated With Survival Multicentre Prospective Observational Register

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734365
• Other study ID #: P 22/13
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: December 2027

Study information

• Verified date: February 2023
• Source: Versailles Hospital
• Contact: Alexis Ferré, MD
• Phone: +33139638700
• Email: aferre[@]ght78sud.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

COPD is one of the leading causes of morbidity, mortality and health care utilisation worldwide. Currently, COPD is the third leading cause of death worldwide and is therefore a major public health problem. Projections show an increase in the prevalence and burden of COPD in the coming decades due to ageing populations and continued exposure to risk factors.

In patients with COPD, mortality due to exacerbations is about 35%. Exacerbations represent the most important respiratory event in the history of this chronic disease and are of major socio-economic interest (about 50-75% of healthcare expenditure in this disease).

In the most severe cases, COPD exacerbations lead to respiratory distress with hypercapnic ventilatory acidosis requiring ventilatory support. These most severe episodes are common, accounting for 20% of exacerbations and are a signal of advanced disease, with a high risk of future hospitalisations and a limited long-term prognosis.

Despite progress in management, the mortality of these severe acute exacerbations is around 15% in the ICU and 20% in hospital. The long-term prognosis following hospitalisation for an acute exacerbation of COPD is poor with a 5-year mortality of around 50%. On the one hand, the means and treatments likely to improve the prognosis of these patients are of great medical and socio-economic interest, on the other hand, it seems important to identify the elements that may be associated with management failure and to treat them where appropriate.

Thus, improving scientific knowledge thanks to prospective data, evaluating the different characteristics and prognosis of patients hospitalised for a severe acute exacerbation of COPD seems, in the 21st century, a major axis in order to continue to optimise the individual management of these patients but also collectively, given the COPD public health burden.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Age = 40 years old

2. COPD documented or strongly suspected

• Chronic respiratory symptoms (dyspnoea, cough and/or sputum)

• Exposure to a known risk factor for COPD (such as tobacco smoke)

• If available, respiratory function tests showing non- or partially reversible obstructive syndrome (post-bronchodilator ratio FEV1/CV < 0.7)

3. Severe acute exacerbation, defined as a worsening of the patient's usual respiratory symptoms with signs of acute respiratory distress (polypnoea = 30 cycles.min-1 or use of accessory respiratory muscles) and/or hypercapnic acidosis (with PaCO2 = 45 mmHg and pH = 7.35)

4. Admission to an ICU, or a dedicated respiratory intensive care unit

Exclusion Criteria:

1. Known asthma (according to the criteria of the international "Global Initiative for Asthma" guidelines)

2. Patient refusal to participate (information note, application for non-opposition)

Related Conditions & MeSH terms

• COPD Exacerbation Acute

Locations

Country	Name	City	State
France	Centre hospitalier de Versailles	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU survival	vital status at ICU discharge	immediately after hospitalization in ICU
Primary	Day 90 survival	vital status at day 90	90 days after ICU admission
Secondary	One-year survival	Rate of survivors and non-survivors will be assessed at one year; To better understand the one-year survival outcome, numerous factors will be assessed for an association with one-year survival: Demographic characteristics and chronic comorbidities; COPD severity; performans status; chronic use of long term oxygen therapy, systemic steroids or homecare non-invasive ventilation; previous intubation for COPD exacerbation; type of triggering factors of COPD exacerbation; type of treatment used during ICU stay (systemic steroids, intravenous bronchodilators, non-invasive ventilation and invasive ventilation); decision of withholding and withdrawal of care during ICU and hospital stay; further COPD exacerbation between hospital discharge and one year outcome; further COPD exacerbation requiring hospitalization between hospital discharge and one year outcome.; We will perform descriptive analysis and multivariate analysis with odds ratio for each factor	one year after ICU admission
Secondary	Factors associated with ICU mortality	Numerous factors will be assessed for an association with ICU mortality: Demographic characteristics and chronic comorbidities; COPD severity; performans status; chronic use of long term oxygen therapy, systemic steroids or homecare non-invasive ventilation; previous intubation for COPD exacerbation; type of triggering factors of COPD exacerbation; vital parameters at ICU admission (temperature, heart rate, mean arterial pressure, respiratory rate, coma glasgow scale); SAPS 2; arterial blood gaz results prameters at ICU admission; biological sample results at ICU admission; type of treatment used during ICU stay (systemic steroids, intravenous bronchodilators, non-invasive ventilation and invasive ventilation).; We will perform descriptive analysis and multivariate analysis with odds ratio for each factor	immediately after hospitalization in ICU
Secondary	Factors associated with hospital mortality	Numerous factors will be assessed for an association with hospital mortality: Demographic characteristics and chronic comorbidities; COPD severity; performans status; chronic use of long term oxygen therapy, systemic steroids or homecare non-invasive ventilation; previous intubation for COPD exacerbation; type of triggering factors of COPD exacerbation; vital parameters at ICU admission (temperature, heart rate, mean arterial pressure, respiratory rate, coma glasgow scale); SAPS 2; arterial blood gaz results prameters at ICU admission; biological sample results at ICU admission; type of treatment used during ICU stay (systemic steroids, intravenous bronchodilators, non-invasive ventilation and invasive ventilation).; We will perform descriptive analysis and multivariate analysis with odds ratio for each factor	immediately after hospital discharge
Secondary	Factors associated with the need for invasive mechanical ventilation	Numerous factors will be assessed for an association with invasive mechanical ventlation: Demographic characteristics and chronic comorbidities; COPD severity; performans status; chronic use of long term oxygen therapy, systemic steroids or homecare non-invasive ventilation; previous intubation for COPD exacerbation; type of triggering factors of COPD exacerbation; vital parameters at ICU admission (temperature, heart rate, mean arterial pressure, respiratory rate, coma glasgow scale); SAPS 2; arterial blood gaz results prameters at ICU admission; biological sample results at ICU admission; type of treatment before ICU admission (systemic steroids, non-invasive ventilation) and type of treatment used during ICU stay (systemic steroids, intravenous bronchodilators, non-invasive ventilation).; We will perform descriptive analysis and multivariate analysis with odds ratio for each factor	immediately after the intervention named invasive mechanical ventilation