nCD64 vs. Neutrophil/Lymphocyte Ratio for Predicting In-hospital Outcome in AE-COPD

Neutrophil CD64 Versus Neutrophil/Lymphocyte Ratio (NLR) as Markers Predicting In-hospital Outcome in Acute Exacerbation of COPD

Neutrophil CD64 versus Neutrophil/Lymphocyte ratio (NLR) as markers predicting in-hospital outcome in acute exacerbation of COPD

Study Overview

• Status: Completed
• Conditions: Copd; COPD Exacerbation
• Intervention / Treatment: Diagnostic test: nCD64; Diagnostic test: Neutrophil/Lymphocyte Ratio

Detailed Description

Acute exacerbation of COPD is among the most frequent reasons for hospitalisation. Approximately 4% of the general population in the western world is admitted with an acute respiratory disease at least once a year and nearly one fifth of hospital visits is due to acute exacerbation of COPD. Early identifications and management of AE-COPD is an important issue in clinical practice. AE-COPD is accompanied with various worsening respiratory symptoms and deterioration in lung function. Also the frequency and severity of attacks is associated with increased mortality.

During exacerbation, the inflammation in COPD is amplified in comparison with stable periods. The increased level of inflammatory markers is associated with lung function decline. As infection, is the main cause leading to clinical AECOPD, white blood cell counts and ESR are the common markers to show the existence of infection in patients with COPD. Recently, other bio markers are used. Authors have found that the high-affinity Fc receptor-CD64 is expressed by monocytes and only weakly on resting neutrophils. The high-expression of neutrophil CD64 (nCD64) is an early step in the host- immune response to bacterial infection. Studies have shown that the nCD64 might be used as a bio-marker for early-onset sepsis or bacterial infection. However, authors agreed that the value of the nCD64 in COPD prognosis is unknown.

As most of novel bio-markers that identify the severity of acute exacerbation in COPD, are time consuming and expensive, there is a need to use more simple tests. The Neutrophil-lymphocyte ratio is a rapid, easy and cost-effective method derived from routine complete blood count tests in clinical practice. The NLR could be an important marker that assess inflammatory status in patients with COPD and could identify early, acute exacerbation. However, this bio marker has not been widely used in the diagnosis of AECOPD.

The purpose of the present study is: 1- To measure the values of the neutrophil CD64 and NLR in patients with AECOPD and stable COPD, 2- to correlate between nCD64, NLR and the usual routine bio-markers as white blood cell count and erythrocyte sedimentation rate, 3- to investigate the role of nCD64 and NLR as predictors for short term hospital outcome in this group.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • AssiutU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The exacerbation of COPD is defined as the patient being diagnosed with COPD with two or more of the following three symptoms of exacerbations: new or worsening cough, worsened dyspnea, and worsened sputum volume and/or change in its color.

Description

Inclusion Criteria:

• patients diagnosed as AECOPD and stable COPD ( random selection by 1:1 cross over). A diagnosis of COPD was made by a clinical history, examination and spirometer (forced expiratory volume in 1st second/forced vital capacity (FEV1/FVC)ratio of <0.7). The severity of COPD was graded according to the Global Initiative for Chronic Obstructive Lung Disease guidelines.

Exclusion Criteria:

• history of current respiratory disorders other than COPD, malignancy, systemic auto-immune disorders, recent surgery and severe endocrine, hepatic or renal diseases. Patients with pneumonia, cardiovascular and metabolic diseases

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD patients; A diagnosis of COPD was made by a clinical history, examination and spirometer (forced expiratory volume in 1st second/forced vital capacity (FEV1/FVC)ratio of <0.7). The severity of COPD was graded according to the Global Initiative for Chronic Obstructive Lung Disease guidelines. [9] (Stage I, mild COPD: FEV1≥80.0% predicted; Stage II, moderate COPD: FEV1 80-50.0%; Stage III, severe COPD: FEV1 50- 30.0%; Stage IV, very severe COPD: FEV1< 30.0%). The exacerbation of COPD was defined as the patient being diagnosed with COPD with two or more of the following three symptoms of exacerbations: new or worsening cough, worsened dyspnea, and worsened sputum volume and/or change in its color.	Diagnostic test: nCD64; neutrophil CD64; Other Names: neutrophil CD64; Diagnostic test: Neutrophil/Lymphocyte Ratio; Neutrophil/ lymphocyte ratio; Other Names: NLR
control; healthy sex and age matched group	Diagnostic test: nCD64; neutrophil CD64; Other Names: neutrophil CD64; Diagnostic test: Neutrophil/Lymphocyte Ratio; Neutrophil/ lymphocyte ratio; Other Names: NLR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Define the cut off values of the nCD64 and NLR in patients with AE-COPD and stable COPD	level of nCD64 and NLR that define exacerbation	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Can nCD64 and NLR as markers be used as predictors for short term hospital outcome	correlate between level of these markers and hospital outcome	3 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 11, 2016
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): April 20, 2017

Study Registration Dates

• First Submitted: April 22, 2017
• First Submitted That Met QC Criteria: May 7, 2017
• First Posted (ACTUAL): May 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: AssiutU5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No