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CompletedNCT06514599AECOPDUpdated Jul 23, 2024

CRP, Procalcitonin and Pro-BNP as Diagnostic and Prognostic Markers in AECOPD

An observational study in COPD Exacerbation Acute, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
196
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • COPD Exacerbation Acute

Keywords

  • COPD
  • pro-BNP
  • procalcitonin
  • exacerbations
03

In context

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The patients for this study were recruited in the ED between 15/02/2023-15/02/2024.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
196 participants (actual)
Target follow-up
4 Weeks
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Attack Severity

    Mild, Moderate and Severe

    Time frame: At admission

Secondary outcomes

  1. Mortality

    AECOPD-related death

    Time frame: 28 days

07

Study locations

1 site
  • Ministry of Health, University of Health Sciences, İstanbul Kanuni SUltan Suleyman TRaining and Research Hospital
    İstanbul, Küçükçekmece 34303, Turkey
08

References and documents

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 38060225 ↗
  • 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. PubMed 20595157 ↗
  • 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. PubMed 21030489 ↗
  • 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. PubMed 28143877 ↗
  • 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. PubMed 28680355 ↗
  • 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. PubMed 17218551 ↗
  • 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. PubMed 33069326 ↗
  • 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/ PubMed 21510031 ↗
  • 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. PubMed 29904438 ↗
  • 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. PubMed 27906423 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06514599
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Serkan Doğan (Assoc. Prof., Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Jul 23, 2024
Start date
Feb 15, 2023
Primary completion
Feb 15, 2024
Completion
Apr 15, 2024
Last update
Jul 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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