Ventilator Lung Clinical Trial
Official title:
Copeptın as a Dısease Severıty Indıcator: A Prospectıve Case-Control Study
NCT number | NCT06211985 |
Other study ID # | 63-2023 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 12, 2023 |
Est. completion date | November 2, 2023 |
Verified date | January 2024 |
Source | Haseki Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | UHS Haseki Training and Research Hospital | Istanbul | Sultangazi |
Lead Sponsor | Collaborator |
---|---|
Berker Okay |
Turkey,
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
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 |
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