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

NCT06064487 | Completed

• 1 other identifier: markers of septic AKI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

AKI - Acute Kidney Injury

Keywords

AKI; sepsis; markers; urine sediment

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• need for renal replacement therapy

  90 days

• mortality

  90 days

• length of ICU and hospital stay

  90 days

Study Arms (1)

septic AKI patients

EXPERIMENTAL

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

Diagnostic Test: renal cell arrest and damage biomarkers assessment

Interventions

renal cell arrest and damage biomarkers assessment DIAGNOSTIC_TEST

measurement of TIMP2 and IGFBP7, KIM-1

septic AKI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

Location

Related Publications (4)

• Gordon AC, Mason AJ, Thirunavukkarasu N, Perkins GD, Cecconi M, Cepkova M, Pogson DG, Aya HD, Anjum A, Frazier GJ, Santhakumaran S, Ashby D, Brett SJ; VANISH Investigators. Effect of Early Vasopressin vs Norepinephrine on Kidney Failure in Patients With Septic Shock: The VANISH Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):509-18. doi: 10.1001/jama.2016.10485.

  PMID: 27483065 BACKGROUND

• Maizel J, Daubin D, Vong LV, Titeca-Beauport D, Wetzstein M, Kontar L, Slama M, Klouche K, Vinsonneau C. Urinary TIMP2 and IGFBP7 Identifies High Risk Patients of Short-Term Progression from Mild and Moderate to Severe Acute Kidney Injury during Septic Shock: A Prospective Cohort Study. Dis Markers. 2019 Apr 1;2019:3471215. doi: 10.1155/2019/3471215. eCollection 2019.

  PMID: 31061681 BACKGROUND

• Gunnerson KJ, Shaw AD, Chawla LS, Bihorac A, Al-Khafaji A, Kashani K, Lissauer M, Shi J, Walker MG, Kellum JA; Sapphire Topaz investigators. TIMP2*IGFBP7 biomarker panel accurately predicts acute kidney injury in high-risk surgical patients. J Trauma Acute Care Surg. 2016 Feb;80(2):243-9. doi: 10.1097/TA.0000000000000912.

  PMID: 26816218 BACKGROUND

• Elsayed MM, Eldeeb AE, Tahoun MM, El-Wakil HS, Naga SS. Does combining urine sediment examination to renal cell arrest and damage biomarkers improve prediction of progression and mortality of sepsis associated acute kidney injury? BMC Nephrol. 2025 Apr 17;26(1):195. doi: 10.1186/s12882-025-04096-1.

  PMID: 40247231 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Sepsis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hala S ElWakil, MD

  professor

  STUDY CHAIR

• salah s naga, MD

  professor

  PRINCIPAL INVESTIGATOR

• Mohamed mamdouh Elsayed, MD

  Lecturer

  STUDY CHAIR

• Mona m tahoun, MD

  Lecturer

  STUDY CHAIR

• ahmed E El-deeb, Master

  assistant lecturer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 3, 2023
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

EG (1)