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Completed

NCT Number: NCT06211985

Copeptin: Disease Severity Indicator

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.

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Key information

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHS Haseki Training and Research Hospital

Istanbul, Sultangazi, 34304, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Copeptin level measurement

Diagnostic Test

Throughout the study period, a total of 202 eligible patients were admitted to the hospital. Twenty-four patients were excluded due to lack of consent from their families, and an additional 103 patients were excluded based on the predefined exclusion criteria. In the control group, 72 individuals without chronic or acute diseases were initially eligible, but 46 of them were excluded due to lack of consent from their families. The study included patients who met the inclusion criteria and whose families provided consent, and it concluded upon reaching a total of 25 patients for each group. Additional blood samples were collected from each child within every group to assess copeptin levels, in conjunction with routine tests

Primary outcomes

  1. Predict disease severity in children with pneumonia with copeptin

    Time frame: 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 outcomes

  1. Copeptin is more powerful than other acute phase reactants in predicting disease severity.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Berker Okay

Other

Registry information

Official study title

Copeptın as a Dısease Severıty Indıcator: A Prospectıve Case-Control Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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