Skip to main content
OpenTrials
Completed

NCT Number: NCT05310812

Evaluation of Candidate Biomarkers to Predict Disease Severity and Acute Kidney Injury in Sepsis Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with sepsis and septic shock according to the "The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)" guideline.
  • Signing of the Informed Consent Form by the patient or his legal representative.

Exclusion criteria

  • Patients under 18 years of age.
  • They are pregnant.
  • Malignant patients in the terminal period with no expected survival.
  • The Informed Consent Form is not signed by the patient or patient's relative.
  • Sepsis and septic shock patients admitted from another hospital under vasopressor or on mechanical ventilator.
  • Patients who develop brain damage and multi-organ failure after cardiopulmonary resuscitation.
  • Chronic renal failure patients receiving dialysis treatment.

Treatment and study plan

Biochemical evaluation.

Diagnostic Test

Blood will be taken for biochemical evaluation-ELISA.

Other names: Presepsin, NGAL, Syndecan-1, Proencephalin

Primary outcomes

  1. Acute kidney injury

    Time frame: 1st day in ICU

    KDIGO classification for acute kidney injury and biomarkers (ELISA test for Presepsin, Proencephalin, Syndecan-1 NGAL)

  2. Mortality

    Time frame: 1st day in ICU

    Relationship between mortality rates and biomarkers (CRP, procalcitonin, white blood cell count, ELISA test for Presepsin, Proencephalin, Syndecan-1, NGAL.

Secondary outcomes

  1. Disesase severity

    Time frame: 1st day in ICU

    Relationship between APACHE-SOFA scores and biomarkers (ELISA test for Presepsin, Proencephalin, Syndecan-1, NGAL)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Evaluation of Candidate Biomarkers to Predict Disease Severity and Acute Kidney Injury in Sepsis Patients in the Intensive Care Unit: Prospective Observational Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.