Assessment of Trace Elements, Systemic Inflammation and Electrolytes

Copd Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05718453
• Other study ID #: Rasha Abdelfattah
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: February 2023
• Source: Egymedicalpedia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 15, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Copd
• Inflammation

Intervention

Combination Product:
• Laboratory Tests
Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.

Locations

Country	Name	City	State
Egypt	Minia university	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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