COPD Exacerbation AcuteCOPD-ICUNCT05734365
COPD-ICU Multicentre Prospective Observational Register
An observational study of COPD Exacerbation Acute, run by Versailles Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation Acute
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2022to Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to ICU, a step-unit or respiratory care unit for a severe acute exacerbation of COPD
Who may be able to join
- Age ≥ 40 years old
- 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)
- 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)
- Admission to an ICU, or a dedicated respiratory intensive care unit
Who cannot join
- Known asthma (according to the criteria of the international "Global Initiative for Asthma" guidelines)
- Patient refusal to participate (information note, application for non-opposition)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre hospitalier de Versailles
Le Chesnay, 78150
Alexis Ferré, MD, +33139638700, aferre@ght78sud.fr
Laure Morisset, +3339239785, lmorisset@ght78sud.fr
About this study
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
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).
Read more
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.
- Conditions
- COPD Exacerbation Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU survival
vital status at ICU discharge
Measured: immediately after hospitalization in ICU
Day 90 survival
vital status at day 90
Measured: 90 days after ICU admission
Secondary outcomes (4)
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
Measured: one year after ICU admission
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
Measured: immediately after hospitalization in ICU
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
Measured: immediately after hospital discharge
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
Measured: immediately after the intervention named invasive mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Nov 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Exacerbation AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis FERRE, Versailles Hospital
- Investigators
- Alexis Ferré, MD, Principal investigator, Centre hospitalier de Versailles, 78150, Le Chesnay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734365
- Sponsor's protocol ID
- P 22/13
- Acronym
- COPD-ICU
- Status last verified
- Feb 2023
- First submitted
- 28 Jan 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05734365
- Acronym / sponsor ID
- COPD-ICU / P 22/13
- Conditions
- COPD Exacerbation Acute
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to ICU, a step-unit or respiratory care unit for a severe acute exacerbation of COPD
Key inclusion criteria (7 listed)
- Age ≥ 40 years old
- COPD documented or strongly suspected
- 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)
- Admission to an ICU, or a dedicated respiratory intensive care unit
Key exclusion criteria (2 listed)
- Known asthma (according to the criteria of the international "Global Initiative for Asthma" guidelines)
- Patient refusal to participate (information note, application for non-opposition)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU survival
Time frame: immediately after hospitalization in ICU
vital status at ICU discharge
Day 90 survival
Time frame: 90 days after ICU admission
vital status at day 90
4 secondary outcomes
One-year survival
Time frame: one year after ICU admission
Factors associated with ICU mortality
Time frame: immediately after hospitalization in ICU
Factors associated with hospital mortality
Time frame: immediately after hospital discharge
Factors associated with the need for invasive mechanical ventilation
Time frame: immediately after the intervention named invasive mechanical ventilation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexis Ferré, MD principal investigator
Centre hospitalier de Versailles, 78150, Le Chesnay
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation Acute, run by Versailles Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis Ferré, MD (+33139638700, aferre@ght78sud.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU survival (time frame: immediately after hospitalization in ICU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.