Copeptin: Disease Severity Indicator

Not Applicable

Completed

• Conditions: Bronchitis; Lower Respiratory Tract and Lung Infections; Ventilator Lung; Bronchopneumonia
• Interventions: Diagnostic Test: Copeptin level measurement

• Registration Number: NCT06211985
• Lead Sponsor: Berker Okay

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-12
• Primary Completion: 2023-10-02
• Study Completion: 2023-11-02
• Study First Submitted: 2023-12-23
• Study First Submitted QC: 2024-01-09
• Study First Posted: 2024-01-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe Pneumonia Group	Copeptin level measurement	patients admitted to the ward with a diagnosis of severe pneumonia (Group 2)
Mild to Moderate Pneumonia Group	Copeptin level measurement	patients admitted to the ward with a diagnosis of mild to moderate pneumonia (Group 2)
Bronchiolitis Group	Copeptin level measurement	patients admitted to the ward with a diagnosis of Bronchiolitis (Group 1)
Control Group	Copeptin level measurement	the control group without pneumonia (Group 4)

Primary Outcome Measures

Name	Time	Method
Predict disease severity in children with pneumonia with copeptin	1 months	Copeptin may hold promise as a predictor of disease severity in children with lower respiratory tract infections. It may show potential to guide physicians in determining the need for hospitalization and ventilator support.; To measure this, patients were divided into groups and copeptin values of patients who needed ventilator support or who were hospitalized were compared with copeptin values of others using SPSS statistical program.

Secondary Outcome Measures

Name	Time	Method
Copeptin is more powerful than other acute phase reactants in predicting disease severity.	1 months	Copeptinin may perform better than other acute phase reactants such as neutrophil to lymphocyte ratio, fibrinogen to albumin ratio, c-reactive protein and procalcitonin in indicating the severity of the disease.; To measure this, patients were divided into groups and copeptin values of patients who needed ventilator support or who were hospitalized were compared with copeptin values of others using SPSS statistical program.

Trial Locations

Locations (1)

UHS Haseki Training and Research Hospital; 🇹🇷 Istanbul, Sultangazi, Turkey