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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock; Acute Kidney Injury
• Intervention / Treatment: Diagnostic test: Biochemical evaluation.

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.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Istanbul University, Istanbul Faculy of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with sepsis and septic shock according to the "The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)" guideline.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group (Sepsis - no acute kindey injury); Septic patients diagnosed by sepsis criteria but no have an acute kidney injury. (According ot KDIGO classification - creatinin values). Blood plasma will be taken for biochemical evaluation.	Diagnostic test: Biochemical evaluation.; Blood will be taken for biochemical evaluation-ELISA.; Other Names: Syndecan-1; Presepsin; NGAL; Proencephalin
Study group (Sepsis induced acute kidney injury); Septic patients diagnosed by sepsis criteria, and have an acute kidney injury. (According ot KDIGO classification - creatinin values). Blood plasma will be taken for biochemical evaluation.	Diagnostic test: Biochemical evaluation.; Blood will be taken for biochemical evaluation-ELISA.; Other Names: Syndecan-1; Presepsin; NGAL; Proencephalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute kidney injury	KDIGO classification for acute kidney injury and biomarkers (ELISA test for Presepsin, Proencephalin, Syndecan-1 NGAL)	1st day in ICU
Mortality	Relationship between mortality rates and biomarkers (CRP, procalcitonin, white blood cell count, ELISA test for Presepsin, Proencephalin, Syndecan-1, NGAL.	1st day in ICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disesase severity	Relationship between APACHE-SOFA scores and biomarkers (ELISA test for Presepsin, Proencephalin, Syndecan-1, NGAL)	1st day in ICU

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Director: Figen ESEN, Prof. Dr., Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: February 27, 2022
• First Submitted That Met QC Criteria: March 26, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Sepsis; Acute Kidney Injury; Presepsin; Proenkefalin; Sindekan-1
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Kidney Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Toxemia; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 2021/1907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No