Clinical trial NCT06211985: Copeptin: Disease Severity Indicator
Official title: Copeptın as a Dısease Severıty Indıcator: A Prospectıve Case-Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Respiratory Tract and Lung Infections
Ventilator Lung
Bronchopneumonia
Bronchitis
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 101
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blood tests were taken from all children included in the study to study the biomarker called 'Copeptin'.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Predict disease severity in children with pneumonia with copeptin
timeFrame: 1 months
Secondary outcomes:
measure: Copeptin is more powerful than other acute phase reactants in predicting disease severity.
timeFrame: 1 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: UHS Haseki Training and Research Hospital
state: Sultangazi
Study officials:
References:
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.
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.
citation: 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.
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.
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.
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.