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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06064487
Enrollment
80
Registered
2023-10-03
Start date
2023-10-01
Completion date
2024-06-01
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AKI - Acute Kidney Injury

Keywords

AKI, sepsis, markers, urine sediment

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTrenal cell arrest and damage biomarkers assessment

measurement of TIMP2 and IGFBP7, KIM-1

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Urinary TIMP2 and IGFBP7 estimation90 daysboth will be measured by the ELISA technique
Urinary KIM-1 estimation90 dayswill be measured by the ELISA technique
Examination of urine sediment7 daysby calculating Perazella score
progression of AKI90 daysby assessing change in eGFR

Secondary

MeasureTime frameDescription
need for renal replacement therapy90 daysneed of any dialysis modality
mortality90 daysdeath
length of ICU and hospital stay90 daysduration of stay

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026