Assessment of Trace Elements, Systemic Inflammation and Electrolytes

Study Overview
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Brief Summary
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COPD is one of the most common causes of health problems worldwide. It is a disease that is associated with several systemic features that affect its morbidity and mortality.

Detailed Description
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The most prominent features of COPD are systemic inflammation and oxidative stress. There is growing interest in establishing the significance of systemic inflammatory biomarkers in COPD patients, as they could be useful in evaluating exacerbations, monitoring disease progression, and evaluating treatment outcomes. C-reactive protein (CRP) is a biomarker for systemic inflammation, produced mostly by hepatocytes in response to tissue injury or inflammation. Tumor necrosis factor - alpha (TNF-α) is a key modulator of the immune system's response to infection. At the sites of inflammation, this cytokine regulates the function of poly-morphs and lymphocytes, with essentially protective benefits for the host. Increased TNF-α production may enhance an injury process locally and also elevated circulating levels may have negative systemic consequences. Trace elements are hypothesized to play a role in the pathogenesis of many diseases, either directly or indirectly. Trace elements play an important function in the inhibition and activation of enzyme processes . Zinc, for example, is a co-factor for various enzymes and is important for cell membrane stability, protein synthesis, proper tissue growth, and nucleic acid metabolism. Severity of COPD exacerbation is associated with increased levels of copper (Cu) and zinc (Zn). Patients with COPD are liable for various electrolyte derangements, especially during exacerbations. Hyponatremia is typically observed in the final stages of COPD. Hypokalemia may also occur independently or concomitantly with hyponatremia, and because magnesium plays a role in muscle tone, a drop in magnesium levels in COPD is a component that reduces respiratory muscle function and causes muscle fatigue.

Official Title
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Assessment of Trace Elements, Systemic Inflammation and Electrolytes in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Copd

Intervention / Treatment
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* Combination Product: Laboratory Tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD patients Exclusion Criteria: Patients with Cardiovascular diseases, diabetes mellitus, chronic kidney disease, chronic liver disease, collagen vascular diseases, cancer, currently smoking, current pneumonia or inflammation, or refused to participate in the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COPD patients<br>It is about 60 patients with Stable COPD | Combination Product: Laboratory Tests<br>* Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.<br>|
| Active Comparator: Acute exacerbation COPD<br>It is about 40 patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). | Combination Product: Laboratory Tests<br>* Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.<br>|
| Placebo Comparator: healthy controls<br>It is about 40 healthy controls were included in the study | Combination Product: Laboratory Tests<br>* Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the pain resulted in COPD | The Pain was measured by using the visual analogue score (VAS) as Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain | from baseline to 72 hours | 
| Number of participants with abnormal laboratory test results | he study tried to assess some Laboratory Tests in blood and comparing the level of their results in patients with stable and patients with exacerbation of theirs disease and aslo comparing their values between patients who needed and those who did not need mechanical ventilation | from baseline to 48 hours after the taking blood samle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Biomarkers, Trace elements, Electrolytes