Assessment of Trace Elements, Systemic Inflammation and Electrolytes

Phase 1

Completed

• Conditions: Copd
• Interventions: Combination Product: Laboratory Tests

• Registration Number: NCT05718453
• Lead Sponsor: Egymedicalpedia

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-15
• Study First Submitted: 2023-01-04
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-06
• Last Update Submitted: 2023-02-06
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COPD patients	Laboratory Tests	It is about 60 patients with Stable COPD
Acute exacerbation COPD	Laboratory Tests	It is about 40 patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
healthy controls	Laboratory Tests	It is about 40 healthy controls were included in the study

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormal laboratory test results	from baseline to 48 hours after the taking blood samle	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
Assessment of the pain resulted in COPD	from baseline to 72 hours	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

Trial Locations

Locations (1)

Minia university; 🇪🇬 Minya, Egypt