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

Not Applicable

Completed

• Conditions: AKI - Acute Kidney Injury
• Interventions: Diagnostic Test: renal cell arrest and damage biomarkers assessment

• Registration Number: NCT06064487
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-26
• Study Start: 2023-10-01
• Study First Posted: 2023-10-03
• Primary Completion: 2024-04-01
• Status Verified: 2024-06
• Study Completion: 2024-06-01
• Last Update Submitted: 2024-06-15
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
septic AKI patients	renal cell arrest and damage biomarkers assessment	80 patients with sepsis associated AKI stage 1 or 2 according to KDIGO definition

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
mortality	90 days	death
need for renal replacement therapy	90 days	need of any dialysis modality
length of ICU and hospital stay	90 days	duration of stay

Trial Locations

Locations (1)

Faculty of Medicine, Aexandria University; 🇪🇬 Alexandria, Egypt