Interoception and Symptom Perception in Acute COPD Exacerbation
NCT07719231
Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Dyssomnias
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT07693127
The purpose of this study is to evaluate if standard, easily accessible blood tests can help doctors predict the severity and outcomes of sudden flare-ups in patients with Chronic Obstructive Pulmonary Disease (COPD).
When a patient's COPD suddenly worsens, an event called an acute exacerbation, it can lead to serious health complications, breathing difficulties, and hospitalization. Currently, doctors need simple and cost-effective ways to figure out early on which patients are at the highest risk for severe complications.
This observational study will focus on specific components of a routine Complete Blood Count (CBC) test. Researchers will look at the size, volume, and variation of red blood cells (such as Red Cell Distribution Width, or RDW) and platelets. Both red blood cells and platelets are known to be affected by the body's systemic inflammatory response during a severe COPD flare-up.
Participants will include adults over 18 years old who are admitted to the hospital for an acute exacerbation of COPD. As part of the study, researchers will collect and analyze routine clinical data, including:
* Medical history and physical examination findings (including dyspnea severity). * Standard laboratory blood tests (evaluating red blood cells, platelets, kidney and liver function, and inflammation markers). * Arterial blood gas levels. * Pulmonary function tests (breathing tests to measure lung capacity). * High-resolution computed tomography (HRCT) chest scans.
By analyzing this information, the study aims to determine if red blood cell and platelet indices can accurately predict important clinical outcomes. These outcomes include the need for Intensive Care Unit (ICU) admission, the need for a mechanical ventilator (breathing machine), the total length of the hospital stay, and in-hospital mortality. Identifying reliable biomarkers could help healthcare providers make faster, more targeted treatment decisions for COPD patients.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder characterized by persistent airflow limitation and a heightened inflammatory response in the airways. While traditionally viewed strictly as a pulmonary condition, COPD is now widely understood to encompass systemic inflammation, oxidative stress, and immune dysregulation. The clinical trajectory of COPD is frequently punctuated by acute exacerbations (AECOPD), defined as a sudden and severe worsening of respiratory symptoms. These exacerbations accelerate lung function decline, increase the risk of acute respiratory failure (ARF), and are associated with recurrent hospitalizations and high mortality rates.
During an AECOPD, patients experience high-grade systemic inflammation, which is typically reflected by elevated conventional markers such as C-reactive protein (CRP). However, there is a pressing clinical need for more accessible, rapid, and cost-effective biomarkers to aid in early risk stratification upon hospital admission.
Routine hematological analysis, specifically the complete blood count (CBC), offers several promising, non-invasive prognostic markers.
Red Cell Distribution Width (RDW) is a quantitative measure of anisocytosis (variability in red blood cell size). Evidence indicates that elevated RDW is not just a marker of anemia, but reflects underlying chronic inflammation, oxidative stress, and impaired erythropoiesis. In COPD, elevated RDW has been correlated with disease severity, hypercapnia, prolonged hospital stays, and increased risk of in-hospital and ICU mortality.
Furthermore, platelets are critical mediators in inflammatory processes and endothelial dysfunction. Platelet activation plays a role in the pathophysiology of COPD exacerbations. Inflammatory cytokines can interfere with megakaryopoiesis, altering platelet production and activation dynamics. Consequently, indices such as Mean Platelet Volume (MPV), Platelet Distribution Width (PDW), Plateletcrit (PCT%), and the Platelet Large Cell Ratio (P-LCR) undergo significant changes during an acute exacerbation.
Despite this evidence, the combined clinical utility of RDW and specific platelet indices in predicting distinct severity grades and clinical outcomes in real-world AECOPD management remains incompletely defined.
This prospective cohort study aims to evaluate the combined prognostic utility of these basic hematological indices. Patients admitted to the Chest Diseases and Tuberculosis Department with a primary diagnosis of AECOPD will be evaluated.
Upon enrollment, all participants will undergo a comprehensive clinical assessment, including a detailed medical history and physical examination. Dyspnea severity will be clinically graded.
The diagnostic and assessment workflow includes:
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Dyspnea severity will be quantified using the modified Medical Research Council (mMRC) dyspnea scale. This scale evaluates the degree of breathlessness on a grading system from 0 to 4, with higher grades indicating more severe symptoms.
Time frame: From the date of hospital admission until the date of hospital discharge, assessed up to 30 days.
The total number of days the patient remains hospitalized for the treatment of the acute exacerbation of COPD.
Assiut University
Other
Assessment of Red Blood Cell and Platelet Indices in Predicting Outcome in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07719231
Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Dyssomnias
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07508943
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Hangzhou, Zhejiang, China
View Trial DetailsNCT07393685
Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Infections
Tianjin, Tianjin Municipality, China
View Trial DetailsNCT06918353
Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Disease
Zhengzhou, Henan, China
View Trial Details