Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT05310812
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2022-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Candidate Biomarkers to Predict Disease Severity and Acute Kidney Injury in Sepsis Patients
Sponsor:
Istanbul University
Organization:
Study Overview
Official Title:
Evaluation of Candidate Biomarkers to Predict Disease Severity and Acute Kidney Injury in Sepsis Patients in the Intensive Care Unit: Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigators predict that the information that can be obtained in terms of renal functions before clinical development in sepsis patients can be valuable in terms of guiding treatment algorithms, planning renal replacement therapies and using drugs that are toxic to the kidneys.
Detailed Description:
Despite the developments in Intensive Care Units (ICU), mortality and morbidity rates due to sepsis and septic shock are still high and it is seen as one of the major causes of death in ICU patients. Acute kidney injury (AKI) is a common disease worldwide and is seen in approximately 60% of intensive care hospitalizations. Diagnosis is generally made by the increase in serum creatinine level. Although it is a basic marker for AKI in current conditions, its levels can be misleading in clinical practice, especially in sepsis patients characterized by clinical conditions such as multiple organ failure. For these reasons, there is a need for new and applicable biomarkers that can be used in planning organ support treatments that can be applied to renal function in sepsis patients.
The utility of a new marker called presepsin in disease course, prognosis determination and sepsis-associated AKI clinic has been demonstrated. There are studies showing that neutrophil gelatinase-associated lipocalin (NGAL) is more valuable when compared to creatinine in patients with sepsis-associated AKI. Proenkephalin is a new biomarker studied, and it has been studied with NGAL in patients with cardiogenic shock, and it has been shown to have a place in the prediction of AKI in patients with cardiogenic shock. Significant elevation of syndecan-1 in acute kidney injury has been demonstrated in animal studies and clinical studies. In the literature, as far as investigators know, proenkephalin and syndecan-1 have not been studied in terms of AKI in sepsis patients.
In our study, investigators plan to investigate the role of biomarkers such as presepsin, syndecan-1, NGAL, and proenkephalin in predicting the risk of developing AKI in sepsis patients. The relevant markers will be studied from the blood sample taken from the patients diagnosed with sepsis at the time of diagnosis, and the results will be analyzed in terms of markers that may be more useful in predicting the development of AKI in patients. In addition, investigators aim to obtain clinical information by investigating whether these biomarkers have predictive properties on disease prognosis and mortality.
The utility of a new marker called presepsin in disease course, prognosis determination and sepsis-associated AKI clinic has been demonstrated. There are studies showing that neutrophil gelatinase-associated lipocalin (NGAL) is more valuable when compared to creatinine in patients with sepsis-associated AKI. Proenkephalin is a new biomarker studied, and it has been studied with NGAL in patients with cardiogenic shock, and it has been shown to have a place in the prediction of AKI in patients with cardiogenic shock. Significant elevation of syndecan-1 in acute kidney injury has been demonstrated in animal studies and clinical studies. In the literature, as far as investigators know, proenkephalin and syndecan-1 have not been studied in terms of AKI in sepsis patients.
In our study, investigators plan to investigate the role of biomarkers such as presepsin, syndecan-1, NGAL, and proenkephalin in predicting the risk of developing AKI in sepsis patients. The relevant markers will be studied from the blood sample taken from the patients diagnosed with sepsis at the time of diagnosis, and the results will be analyzed in terms of markers that may be more useful in predicting the development of AKI in patients. In addition, investigators aim to obtain clinical information by investigating whether these biomarkers have predictive properties on disease prognosis and mortality.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: