Copeptin: Disease Severity Indicator

Berker Okay

Status: Completed

Conditions: Ventilator Lung; Lower Respiratory Tract and Lung Infections; Bronchitis; Bronchopneumonia

Treatments: Diagnostic Test: Copeptin level measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT06211985

63-2023

Details and patient eligibility

About

Copeptin serves as a biomarker emanating from the pituitary gland, functioning as the precursor to arginine vasopressin (AVP). Its role in the regulation of endothelial dysfunction, inflammation, and water-electrolyte balance has been established. The measurement of AVP levels poses challenges due to its brief half-life and the intricate nature of its detection method. In contrast, copeptin provides an indirect means of gauging circulating AVP levels, as it can be conveniently assessed through a sandwich immunoassay. As a neuroendocrine stress hormone, copeptin emerges as a prognostic indicator, reflective of an individual's stress burden. Moreover, its applicability extends to various acute conditions such as ischemic stroke or myocardial infarction. Notably, copeptin proves to be a dependable tool in the differential diagnosis of diverse ailments characterized by polyuria and polydipsia.

Lower respiratory tract infection (LRTI) stands as the predominant cause of morbidity and mortality among children and adolescents globally. Notably, copeptin has demonstrated utility in forecasting the severity and complications associated with severe pneumonia in adults. While early investigations into copeptin's role in pediatric LRTI suggest its potential for diagnosing pneumonia and predicting complications, the outcomes of these studies present conflicting results.

Although there has been a notable increase in studies on copeptin in pediatric patients over the past decade, research specifically exploring its correlation with pneumonia remains scarce. This prospective case-control study is designed to investigate the potential association between copeptin levels and the severity of illness in pediatric patients with pneumonia. The study aims to determine whether copeptin levels can serve as a reliable predictor of disease severity in pneumonia, offering valuable insights for clinical application. The outcomes of this research may contribute significantly to our comprehension of copeptin's role in disease prognosis and management, thereby facilitating the development of more efficacious diagnostic and therapeutic approaches. Additionally, the study seeks to identify the factors influencing copeptin levels and establish a cut-off value for copeptin in pediatric patients diagnosed with pneumonia.

Enrollment: 101 patients

Sex: All

Ages: 1 month to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Being diagnosed with pneumonia,
• The family must have given informed consent for the study.

Exclusion criteria

• Individuals with underlying lung conditions (such as cystic fibrosis, bronchopulmonary dysplasia, asthma, bronchiectasis, tuberculosis),
• Individuals with underlying chronic illnesses (inclusive of heart, kidney, liver, gastrointestinal, and endocrine disorders),
• Individuals with obesity or malnutrition,
• Individuals with hyponatremia detected in their tests,
• Individuals with signs of dehydration,
• Individuals with a history of hospitalization within the last 72 hours.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 4 patient groups

Bronchiolitis Group

Active Comparator group

Description:

patients admitted to the ward with a diagnosis of Bronchiolitis (Group 1)

Treatment:

Diagnostic Test: Copeptin level measurement

Mild to Moderate Pneumonia Group

Active Comparator group

Description:

patients admitted to the ward with a diagnosis of mild to moderate pneumonia (Group 2)

Treatment:

Diagnostic Test: Copeptin level measurement

Severe Pneumonia Group

Active Comparator group

Description:

patients admitted to the ward with a diagnosis of severe pneumonia (Group 2)

Treatment:

Diagnostic Test: Copeptin level measurement

Control Group

Active Comparator group

Description:

the control group without pneumonia (Group 4)

Treatment:

Diagnostic Test: Copeptin level measurement