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

Primary Purpose

AKI - Acute Kidney Injury

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

renal cell arrest and damage biomarkers assessment

About this trial

This is an interventional diagnostic trial for AKI - Acute Kidney Injury focused on measuring AKI, sepsis, markers, urine sediment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Faculty of Medicine, Aexandria University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

septic AKI patients

Arm Description

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

Outcomes

Primary Outcome Measures

Urinary TIMP2 and IGFBP7 estimation

both will be measured by the ELISA technique

Urinary KIM-1 estimation

will be measured by the ELISA technique

Examination of urine sediment

by calculating Perazella score

progression of AKI

by assessing change in eGFR

Examination of urine sediment

by calculating Chawla score

Secondary Outcome Measures

need for renal replacement therapy

need of any dialysis modality

mortality

death

length of ICU and hospital stay

duration of stay

Full Information

NCT ID

NCT06064487

First Posted

September 21, 2023

Last Updated

September 26, 2023

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT06064487

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2023 (Anticipated)

Primary Completion Date

February 1, 2024 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

AKI - Acute Kidney Injury

Keywords

AKI, sepsis, markers, urine sediment

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

septic AKI patients

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

renal cell arrest and damage biomarkers assessment

Intervention Description

measurement of TIMP2 and IGFBP7, KIM-1

Primary Outcome Measure Information:

Title

Urinary TIMP2 and IGFBP7 estimation

Description

both will be measured by the ELISA technique

Time Frame

90 days

Title

Urinary KIM-1 estimation

Description

will be measured by the ELISA technique

Time Frame

90 days

Title

Examination of urine sediment

Description

by calculating Perazella score

Time Frame

7 days

Title

progression of AKI

Description

by assessing change in eGFR

Time Frame

90 days

Title

Examination of urine sediment

Description

by calculating Chawla score

Time Frame

7 days

Secondary Outcome Measure Information:

Title

need for renal replacement therapy

Description

need of any dialysis modality

Time Frame

90 days

Title

mortality

Description

death

Time Frame

90 days

Title

length of ICU and hospital stay

Description

duration of stay

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Mamdouh Elsayed, MD

Phone

00201068055103

dr_mohamedmamdouh87@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hala S ElWakil, MD

Organizational Affiliation

professor

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

salah s naga, MD

Organizational Affiliation

professor

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohamed mamdouh Elsayed, MD

Organizational Affiliation

Lecturer

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mona m tahoun, MD

Organizational Affiliation

Lecturer

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

ahmed E El-deeb, Master

Organizational Affiliation

assistant lecturer

Official's Role

Study Chair

Facility Information:

Facility Name

Faculty of Medicine, Aexandria University

City

Alexandria

ZIP/Postal Code

21526

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamed Mamdouh Elsayed, MD

Phone

00201068055103

dr_mohamedmamdouh87@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27483065

Citation

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.

Results Reference

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PubMed Identifier

31061681

Citation

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.

Results Reference

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PubMed Identifier

26816218

Citation

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.

Results Reference

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

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