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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-06-01

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.

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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.

Conditions

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AKI - Acute Kidney Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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septic AKI patients

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

Group Type EXPERIMENTAL

renal cell arrest and damage biomarkers assessment

Intervention Type DIAGNOSTIC_TEST

measurement of TIMP2 and IGFBP7, KIM-1

Interventions

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renal cell arrest and damage biomarkers assessment

measurement of TIMP2 and IGFBP7, KIM-1

Intervention Type DIAGNOSTIC_TEST

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No