COPD Exacerbation AcuteAECOPDNCT06514599
CRP, Procalcitonin and Pro-BNP as Diagnostic and Prognostic Markers in AECOPD
An observational study of COPD Exacerbation Acute, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) are one of the chief causes for admission to Emergency Department. AECOPD is a significant cause for mortality and morbidity worldwide. Emergency Medicine Physicians frequently manage these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation Acute
- How many people
- 196 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 15 Apr 2024
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients for this study were recruited in the ED between 15/02/2023-15/02/2024.
Who may be able to join
- being older than 18 years old
- having been diagnosed with COPD by a specialist
- fulfilling the definition of an exacerbation set by GOLD 2024 guide which are having increased dyspnea, cough and sputum in a timespan of less than 14 days with or without tachypnea and tachycardia
- having signed the consent and approval form.
Who cannot join
- being younger than 18 years old
- not having been diagnosed with COPD by a specialist, not fulfilling the definition of an exacerbation set by GOLD 2024 guide
- refusing to sign the consent and approval form.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ministry of Health, University of Health Sciences, İstanbul Kanuni SUltan Suleyman TRaining and Research Hospital
Istanbul, Küçükçekmece, 34303
About this study
Official title: Comparison of The Efficacy of CRP, Procalcitonin and Pro-BNP as Diagnostic and Prognostic Markers in AECOPD
Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) are one of the chief causes for admission to Emergency Department. AECOPD is a significant cause for mortality and morbidity worldwide. Emergency Medicine Physicians frequently manage these patients. Predicting the severity and possible prognosis of AECOPD is an important task for Emergency Medicine Physicians as treatment options and aggressiveness may depend on these predictions. In our study we aimed to compare different biomarkers such as Procalcitonin, Pro-Brain Natriuretic Peptide (Pro-BNP) and C-Reactive Protein (CRP) on their efficacy at predicting the severity and prognosis of AECOPD.
We analyzed the data of the selected 196 patients with the diagnosis AECOPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 guide who were admitted to our Emergency Department between 15/02/2023 and 15/02/2024.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an important health concern worldwide and causes serious mortality and morbidities. Although prevalences can differ across different countries, it was predicted that 480 million people are affected from COPD in 2020 alone (1).
COPD is a condition that is characterized by an irreversible chronic inflammation which occurs within the airways, the pulmonary vasculature and parenchyma of the lungs. As a part of the progress of this disease, cough, dyspnea and sputum production could become almost permanent as symptoms. Furthermore, depending on seasonal changes, COPD can present itself with exacerbations, lowering the life quality of the patient and potentially overloading the healthcare systems across the world.
COPD exacerbations influence the general condition of the patient. They can cause admittance rates of COPD patient to significantly increase. They can also cause mortalities as well. A COPD patient can have a 5-year mortality rate of up to %50 if they are hospitalized with a COPD exacerbation (2). COPD exacerbations are diagnosed with a detailed medical history, physical examination and necessary diagnostic tests. According the GOLD 2024 guidelines, in order to diagnose and classify a patient with a preliminary diagnosis of a COPD exacerbation Visual Analogue Scale (VAS) dyspnea score, respiratory rate, heart rate, resting oxygen saturation, arterial blood gas and C-reactive protein (CRP) levels are among these necessary diagnostic tests.
There are studies mentioning CRP and Procalcitonin levels as independent diagnostic biomarkers for asthma and COPD exacerbations (3). There are also studies with findings that support the idea of using CRP and Procalcitonin levels as independent biomarkers to guide the antibiotic therapy in these patients (3-6). In addition to these markers, Pro Brain Natriuretic Peptide (Pro-BNP) is found to be a potentially effective biomarker in predicting the prognosis of COPD patients, both independently and alongside other cardiac biomarkers in a number of studies (7).
In this study we have aimed to compare the efficacy of CRP, Procalcitonin and Pro-BNP as diagnostic and prognostic markers in COPD patients. We focused specifically on Procalcitonin and Pro-BNP and if there is any potential superiority of these biomarkers against CRP while evaluating COPD exacerbation patients.
This prospective and observational study was conducted in an emergency department (ED) of a tertiary care referral center for the western part of Istanbul. Approximately 80-100 patients with various types of life-threatening emergencies daily receive healthcare service in the red area of the ED. Respiratory distress, dyspnea, and acute lung diseases are leading causes of emergency admission in our department. Our ED involved fully equipped and well-qualified critical care unit and resuscitation areas to provide urgent care and life-saving interventions for those patients. Thus, this study was conducted under optimal infrastructural conditions for patients with COPD exacerbation.
The patients for this study were recruited in the ED between 15/02/2023-15/02/2024. In order to form a database to use for our research, a data collection form was organized for each individual. This form compromised of the patient's saturation without supplemental oxygen, heart rate in beats per minute, blood pressure with both systolic and diastolic values separately recorded, body temperature, Electrocardiogram and respiratory rate, with all of them being measured at admittance. A detailed medical history, including the previous and chronic diseases, prescription medicines, past surgeries or invasive procedures and smoking habits, were also added to this data collection form.
- Conditions
- COPD Exacerbation Acute
- Keywords
- COPD, pro-BNP, procalcitonin, exacerbations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Attack Severity
Mild, Moderate and Severe
Measured: At admission
Secondary outcomes (1)
Mortality
AECOPD-related death
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start15 Feb 2023
- Primary completion15 Feb 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Doğan, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514599
- Sponsor's protocol ID
- KAEK/2023.02.21
- Acronym
- AECOPD
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boers E, Barrett M, Su JG, Benjafield AV, Sinha S, Kaye L, Zar HJ, Vuong V, Tellez D, Gondalia R, Rice MB, Nunez CM, Wedzicha JA, Malhotra A. Global Burden of Chronic Obstructive Pulmonary Disease Through 2050. JAMA Netw Open. 2023 Dec 1;6(12):e2346598. doi: 10.1001/jamanetworkopen.2023.46598.
PubMed 38060225Hoogendoorn M, Hoogenveen RT, Rutten-van Molken MP, Vestbo J, Feenstra TL. Case fatality of COPD exacerbations: a meta-analysis and statistical modelling approach. Eur Respir J. 2011 Mar;37(3):508-15. doi: 10.1183/09031936.00043710. Epub 2010 Jul 1.
PubMed 20595157Bafadhel M, Clark TW, Reid C, Medina MJ, Batham S, Barer MR, Nicholson KG, Brightling CE. Procalcitonin and C-reactive protein in hospitalized adult patients with community-acquired pneumonia or exacerbation of asthma or COPD. Chest. 2011 Jun;139(6):1410-1418. doi: 10.1378/chest.10-1747. Epub 2010 Oct 28.
PubMed 21030489Mathioudakis AG, Chatzimavridou-Grigoriadou V, Corlateanu A, Vestbo J. Procalcitonin to guide antibiotic administration in COPD exacerbations: a meta-analysis. Eur Respir Rev. 2017 Jan 31;26(143):160073. doi: 10.1183/16000617.0073-2016. Print 2017 Jan.
PubMed 28143877Colak A, Yilmaz C, Toprak B, Aktogu S. Procalcitonin and CRP as Biomarkers in Discrimination of Community-acquired Pneumonia and Exacerbation of COPD. J Med Biochem. 2017 Apr 22;36(2):122-126. doi: 10.1515/jomb-2017-0011. eCollection 2017 Apr.
PubMed 28680355Stolz D, Christ-Crain M, Bingisser R, Leuppi J, Miedinger D, Muller C, Huber P, Muller B, Tamm M. Antibiotic treatment of exacerbations of COPD: a randomized, controlled trial comparing procalcitonin-guidance with standard therapy. Chest. 2007 Jan;131(1):9-19. doi: 10.1378/chest.06-1500.
PubMed 17218551GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
PubMed 33069326Wier LM, Elixhauser A, Pfuntner A, Au DH. Overview of Hospitalizations among Patients with COPD, 2008. 2011 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #106. Available from http://www.ncbi.nlm.nih.gov/books/NBK53969/
PubMed 21510031Pantzaris ND, Spilioti DX, Psaromyalou A, Koniari I, Velissaris D. The Use of Serum Procalcitonin as a Diagnostic and Prognostic Biomarker in Chronic Obstructive Pulmonary Disease Exacerbations: A Literature Review Update. J Clin Med Res. 2018 Jul;10(7):545-551. doi: 10.14740/jocmr3458w. Epub 2018 Jun 4.
PubMed 29904438Zhu JJ, Liu LJ. Analysis of factors influenced by the effectiveness of non-invasive ventilation in the treatment of acute exacerbation of chronic obstructive pulmonary disease with different severities. Eur Rev Med Pharmacol Sci. 2016 Nov;20(22):4775-4781.
PubMed 27906423
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Efficacy of CRP, Procalcitonin and Pro-BNP as Diagnostic and Prognostic Markers in AECOPD
- ClinicalTrials.gov ID
- NCT06514599
- Acronym / sponsor ID
- AECOPD / KAEK/2023.02.21
- Conditions
- COPD Exacerbation Acute
- Keywords
- COPD, pro-BNP, procalcitonin, exacerbations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 23 Jul 2024 (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.
Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) are one of the chief causes for admission to Emergency Department. AECOPD is a significant cause for mortality and morbidity worldwide. Emergency Medicine Physicians frequently manage these patients. Predicting the severity and possible prognosis of AECOPD is an important task for Emergency Medicine Physicians as treatment options and aggressiveness may depend on these predictions. In our study we aimed to compare different biomarkers such as Procalcitonin, Pro-Brain Natriuretic Peptide (Pro-BNP) and C-Reactive Protein (CRP) on their efficacy at predicting the severity and prognosis of AECOPD.
We analyzed the data of the selected 196 patients with the diagnosis AECOPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 guide who were admitted to our Emergency Department between 15/02/2023 and 15/02/2024.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an important health concern worldwide and causes serious mortality and morbidities. Although prevalences can differ across different countries, it was predicted that 480 million people are affected from COPD in 2020 alone (1).
COPD is a condition that is characterized by an irreversible chronic inflammation which occurs within the airways, the pulmonary vasculature and parenchyma of the lungs. As a part of the progress of this disease, cough, dyspnea and sputum production could become almost permanent as symptoms. Furthermore, depending on seasonal changes, COPD can present itself with exacerbations, lowering the life quality of the patient and potentially overloading the healthcare systems across the world.
COPD exacerbations influence the general condition of the patient. They can cause admittance rates of COPD patient to significantly increase. They can also cause mortalities as well. A COPD patient can have a 5-year mortality rate of up to %50 if they are hospitalized with a COPD exacerbation (2). COPD exacerbations are diagnosed with a detailed medical history, physical examination and necessary diagnostic tests. According the GOLD 2024 guidelines, in order to diagnose and classify a patient with a preliminary diagnosis of a COPD exacerbation Visual Analogue Scale (VAS) dyspnea score, respiratory rate, heart rate, resting oxygen saturation, arterial blood gas and C-reactive protein (CRP) levels are among these necessary diagnostic tests.
There are studies mentioning CRP and Procalcitonin levels as independent diagnostic biomarkers for asthma and COPD exacerbations (3). There are also studies with findings that support the idea of using CRP and Procalcitonin levels as independent biomarkers to guide the antibiotic therapy in these patients (3-6). In addition to these markers, Pro Brain Natriuretic Peptide (Pro-BNP) is found to be a potentially effective biomarker in predicting the prognosis of COPD patients, both independently and alongside other cardiac biomarkers in a number of studies (7).
In this study we have aimed to compare the efficacy of CRP, Procalcitonin and Pro-BNP as diagnostic and prognostic markers in COPD patients. We focused specifically on Procalcitonin and Pro-BNP and if there is any potential superiority of these biomarkers against CRP while evaluating COPD exacerbation patients.
This prospective and observational study was conducted in an emergency department (ED) of a tertiary care referral center for the western part of Istanbul. Approximately 80-100 patients with various types of life-threatening emergencies daily receive healthcare service in the red area of the ED. Respiratory distress, dyspnea, and acute lung diseases are leading causes of emergency admission in our department. Our ED involved fully equipped and well-qualified critical care unit and resuscitation areas to provide urgent care and life-saving interventions for those patients. Thus, this study was conducted under optimal infrastructural conditions for patients with COPD exacerbation.
The patients for this study were recruited in the ED between 15/02/2023-15/02/2024. In order to form a database to use for our research, a data collection form was organized for each individual. This form compromised of the patient's saturation without supplemental oxygen, heart rate in beats per minute, blood pressure with both systolic and diastolic values separately recorded, body temperature, Electrocardiogram and respiratory rate, with all of them being measured at admittance. A detailed medical history, including the previous and chronic diseases, prescription medicines, past surgeries or invasive procedures and smoking habits, were also added to this data collection form.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients for this study were recruited in the ED between 15/02/2023-15/02/2024.
Key inclusion criteria (4 listed)
- being older than 18 years old
- having been diagnosed with COPD by a specialist
- fulfilling the definition of an exacerbation set by GOLD 2024 guide which are having increased dyspnea, cough and sputum in a timespan of less than 14 days with or without tachypnea and tachycardia
- having signed the consent and approval form.
Key exclusion criteria (3 listed)
- being younger than 18 years old
- not having been diagnosed with COPD by a specialist, not fulfilling the definition of an exacerbation set by GOLD 2024 guide
- refusing to sign the consent and approval form.
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
Attack Severity
Time frame: At admission
Mild, Moderate and Severe
1 secondary outcome
Mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 38060225Boers E, Barrett M, Su JG, Benjafield AV, Sinha S, Kaye L, Zar HJ, Vuong V, Tellez D, Gondalia R, Rice MB, Nunez CM, Wedzicha JA, Malhotra A. Global Burden of Chronic Obstructive Pulmonary Disease Through 2050. JAMA Netw Open. 2023 Dec 1;6(12):e2346598. doi: 10.1001/jamanetworkopen.2023.46598.
- Background: PubMed 20595157Hoogendoorn M, Hoogenveen RT, Rutten-van Molken MP, Vestbo J, Feenstra TL. Case fatality of COPD exacerbations: a meta-analysis and statistical modelling approach. Eur Respir J. 2011 Mar;37(3):508-15. doi: 10.1183/09031936.00043710. Epub 2010 Jul 1.
- Background: PubMed 21030489Bafadhel M, Clark TW, Reid C, Medina MJ, Batham S, Barer MR, Nicholson KG, Brightling CE. Procalcitonin and C-reactive protein in hospitalized adult patients with community-acquired pneumonia or exacerbation of asthma or COPD. Chest. 2011 Jun;139(6):1410-1418. doi: 10.1378/chest.10-1747. Epub 2010 Oct 28.
- Background: PubMed 28143877Mathioudakis AG, Chatzimavridou-Grigoriadou V, Corlateanu A, Vestbo J. Procalcitonin to guide antibiotic administration in COPD exacerbations: a meta-analysis. Eur Respir Rev. 2017 Jan 31;26(143):160073. doi: 10.1183/16000617.0073-2016. Print 2017 Jan.
- Background: PubMed 28680355Colak A, Yilmaz C, Toprak B, Aktogu S. Procalcitonin and CRP as Biomarkers in Discrimination of Community-acquired Pneumonia and Exacerbation of COPD. J Med Biochem. 2017 Apr 22;36(2):122-126. doi: 10.1515/jomb-2017-0011. eCollection 2017 Apr.
- Background: PubMed 17218551Stolz D, Christ-Crain M, Bingisser R, Leuppi J, Miedinger D, Muller C, Huber P, Muller B, Tamm M. Antibiotic treatment of exacerbations of COPD: a randomized, controlled trial comparing procalcitonin-guidance with standard therapy. Chest. 2007 Jan;131(1):9-19. doi: 10.1378/chest.06-1500.
- Background: PubMed 33069326GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
- Background: PubMed 21510031Wier LM, Elixhauser A, Pfuntner A, Au DH. Overview of Hospitalizations among Patients with COPD, 2008. 2011 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #106. Available from http://www.ncbi.nlm.nih.gov/books/NBK53969/
- Background: PubMed 29904438Pantzaris ND, Spilioti DX, Psaromyalou A, Koniari I, Velissaris D. The Use of Serum Procalcitonin as a Diagnostic and Prognostic Biomarker in Chronic Obstructive Pulmonary Disease Exacerbations: A Literature Review Update. J Clin Med Res. 2018 Jul;10(7):545-551. doi: 10.14740/jocmr3458w. Epub 2018 Jun 4.
- Background: PubMed 27906423Zhu JJ, Liu LJ. Analysis of factors influenced by the effectiveness of non-invasive ventilation in the treatment of acute exacerbation of chronic obstructive pulmonary disease with different severities. Eur Rev Med Pharmacol Sci. 2016 Nov;20(22):4775-4781.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jul 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attack Severity (time frame: At admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06514599, which also lists 10 linked publications.
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 23 Jul 2024.