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

Alexandria University

Status: Completed

Conditions: AKI - Acute Kidney Injury

Treatments: Diagnostic Test: renal cell arrest and damage biomarkers assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06064487

markers of septic AKI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

septic AKI patients

Experimental group

Description:

80 patients with sepsis associated AKI stage 1 or 2 according to KDIGO definition

Treatment:

Diagnostic Test: renal cell arrest and damage biomarkers assessment