Copeptin: Disease Severity Indicator

Ventilator Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06211985
• Other study ID #: 63-2023
• Status: Completed
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: November 2, 2023

Study information

• Verified date: January 2024
• Source: Haseki Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 2, 2023
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopneumonia
• Lobar Pneumonia
• Lower Respiratory Tract and Lung Infections
• Pneumonia
• Ventilator Lung

Intervention

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

Locations

Country	Name	City	State
Turkey	UHS Haseki Training and Research Hospital	Istanbul	Sultangazi

Sponsors (1)

Lead Sponsor	Collaborator
Berker Okay

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Abdel-Fattah M, Meligy B, El-Sayed R, El-Naga YA. Serum Copeptin Level as a Predictor of Outcome in Pneumonia. Indian Pediatr. 2015 Sep;52(9):807-8. doi: 10.1007/s13312-015-0723-x. — View Citation

Alcoba G, Manzano S, Lacroix L, Galetto-Lacour A, Gervaix A. Proadrenomedullin and copeptin in pediatric pneumonia: a prospective diagnostic accuracy study. BMC Infect Dis. 2015 Aug 19;15:347. doi: 10.1186/s12879-015-1095-5. — View Citation

Baumann P, Fuchs A, Gotta V, Ritz N, Baer G, Bonhoeffer JM, Buettcher M, Heininger U, Szinnai G, Bonhoeffer J; ProPAED study group. The kinetic profiles of copeptin and mid regional proadrenomedullin (MR-proADM) in pediatric lower respiratory tract infections. PLoS One. 2022 Mar 10;17(3):e0264305. doi: 10.1371/journal.pone.0264305. eCollection 2022. — View Citation

Du JM, Sang G, Jiang CM, He XJ, Han Y. Relationship between plasma copeptin levels and complications of community-acquired pneumonia in preschool children. Peptides. 2013 Jul;45:61-5. doi: 10.1016/j.peptides.2013.04.015. Epub 2013 May 6. — View Citation

Mohamed GB, Saed MA, Abdelhakeem AA, Salah K, Saed AM. Predictive value of copeptin as a severity marker of community-acquired pneumonia. Electron Physician. 2017 Jul 25;9(7):4880-4885. doi: 10.19082/4880. eCollection 2017 Jul. — View Citation

Wrotek A, Jackowska T, Pawlik K. Sodium and copeptin levels in children with community acquired pneumonia. Adv Exp Med Biol. 2015;835:31-6. doi: 10.1007/5584_2014_41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predict disease severity in children with pneumonia with copeptin	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	Copeptin is more powerful than other acute phase reactants in predicting disease severity.	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