Copeptin: Disease Severity Indicator

May 28, 2024 updated by: Berker Okay

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sultangazi
      • Istanbul, Sultangazi, Turkey, 34304
        • UHS Haseki Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
the control group without pneumonia (Group 4)
Diagnostic test: Copeptin level measurement
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
Active Comparator: Bronchiolitis Group
patients admitted to the ward with a diagnosis of Bronchiolitis (Group 1)
Diagnostic test: Copeptin level measurement
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
Active Comparator: Mild to Moderate Pneumonia Group
patients admitted to the ward with a diagnosis of mild to moderate pneumonia (Group 2)
Diagnostic test: Copeptin level measurement
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
Active Comparator: Severe Pneumonia Group
patients admitted to the ward with a diagnosis of severe pneumonia (Group 2)
Diagnostic test: Copeptin level measurement
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Berker Okay

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2023

Primary Completion (Actual)

October 2, 2023

Study Completion (Actual)

November 2, 2023

Study Registration Dates

First Submitted

December 23, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 63-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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