- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06514599
CRP, Procalcitonin and Pro-BNP as Diagnostic and Prognostic Markers in AECOPD (AECOPD)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Küçükçekmece
-
İstanbul, Küçükçekmece, Turkey, 34303
- Ministry of Health, University of Health Sciences, İstanbul Kanuni SUltan Suleyman TRaining and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attack Severity
Time Frame: At admission
|
Mild, Moderate and Severe
|
At admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 28 days
|
AECOPD-related death
|
28 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Wier 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/
- Stolz 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.
- GBD 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. Erratum In: Lancet. 2020 Nov 14;396(10262):1562. doi: 10.1016/S0140-6736(20)32226-1.
- 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.
- Hoogendoorn 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.
- Bafadhel 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.
- Mathioudakis 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.
- Colak 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.
- Pantzaris 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.
- Zhu 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KAEK/2023.02.21
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COPD Exacerbation Acute
-
Asten SantePitié-Salpêtrière HospitalActive, not recruitingCOPD Acute ExacerbationFrance
-
omar hasham mohamedRecruiting
-
Ataturk UniversityNot yet recruitingCOPD Exacerbation Acute
-
Versailles HospitalRecruiting
-
University Hospital, MahdiaUnknownAcute Exacerbation CopdTunisia
-
Inonu UniversityTerminatedCOPD Acute Exacerbation
-
Centre Hospitalier Universitaire, AmiensTerminatedAcute Exacerbation CopdFrance
-
Alung TechnologiesTerminatedAcute Exacerbation of COPDUnited States
-
University of ChicagoNational Heart, Lung, and Blood Institute (NHLBI); COPD Foundation; Society of... and other collaboratorsRecruiting
-
Hospital Quiron Sagrado CorazonNot yet recruiting