Renal Cell Arrest and Damage Biomarkers in Progression and Outcome of Septic AKI

Study Overview
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Brief Summary
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The aim of the current study is to assess the predictive value of renal cell arrest biomarkers (urinary TIMP2 and IGFBP7), renal damage biomarkers (urinary KIM-1) and microscopic examination of urinary sediment in progression and outcome of sepsis associated AKI.

Detailed Description
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Acute kidney injury occurred in about 45-53% of patients with sepsis, and most septic AKI was mild or moderate AKI (KDIGO stage 1 or stage 2). However, previous study showed that up to 40% of these mild or moderate AKI would progress to more severe AKI (KDIGO stage 3), of which 30% required dialysis and the risk of death increased by 3-fold, as high as 70%. Therefore, early identifying patients at high risk for progressive AKI might help clinicians to enhance individualized monitoring and personalized management in patient with septic AKI, which might prevent or halt the ongoing renal injury and improve the outcome of patients with sepsis.

Official Title
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Role of Renal Cell Arrest and Damage Biomarkers in Progression and Outcome of Sepsis Associated AKI

Conditions
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AKI - Acute Kidney Injury

Intervention / Treatment
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* Diagnostic Test: renal cell arrest and damage biomarkers assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AKI stage 1 or 2 according to KDIGO definition. Sepsis is defined based on the third international consensus definitions for sepsis and septic shock (Sepsis-3) as life threatening organ dysfunction caused by a dysregulated host response to infection. At least two of systemic inflammatory response syndrome (SIRS) criteria should be present Exclusion Criteria: Age less than 18 years. Patients with pre-existing chronic kidney disease (eGFR<60 ml/min/1.73m2). Previous renal replacement therapy. Acute kidney injury caused by permanent postrenal obstruction. Pregnancy. Hepatorenal syndrome. Renal transplant recipients. Patients for whom survival to 30 days is unlikely due to end stage disease (end stage liver or heart disease or untreatable malignancy).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The current study will include 80 patients with sepsis associated AKI stage 1 or 2 according to KDIGO definition admitted to Alexandria Main University Hospital. Urinary TIMP2 and IGFBP7: will be measured by the ELISA technique. Urinary KIM-1: will be measured by the ELISA technique. Examination of urine sediment from fresh urine sample.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: septic AKI patients<br>80 patients with sepsis associated AKI stage 1 or 2 according to KDIGO definition | Diagnostic Test: renal cell arrest and damage biomarkers assessment<br>* measurement of TIMP2 and IGFBP7, KIM-1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary TIMP2 and IGFBP7 estimation | both will be measured by the ELISA technique | 90 days | 
| Urinary KIM-1 estimation | will be measured by the ELISA technique | 90 days | 
| Examination of urine sediment | by calculating Perazella score | 7 days | 
| progression of AKI | by assessing change in eGFR | 90 days | 
| Examination of urine sediment | by calculating Chawla score | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for renal replacement therapy | need of any dialysis modality | 90 days | 
| mortality | death | 90 days | 
| length of ICU and hospital stay | duration of stay | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AKI, sepsis, markers, urine sediment