Clinical trial NCT06064487: 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
Overall status: COMPLETED
Phase: NA
Conditions: AKI - Acute Kidney Injury
Keywords: AKI
sepsis
markers
urine sediment
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Urinary TIMP2 and IGFBP7 estimation
timeFrame: 90 days
measure: Urinary KIM-1 estimation
timeFrame: 90 days
measure: Examination of urine sediment
timeFrame: 7 days
measure: progression of AKI
timeFrame: 90 days
measure: Examination of urine sediment
timeFrame: 7 days
Secondary outcomes:
measure: need for renal replacement therapy
timeFrame: 90 days
measure: mortality
timeFrame: 90 days
measure: length of ICU and hospital stay
timeFrame: 90 days
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Aexandria University
Study officials:
affiliation: professor
name: Hala S ElWakil, MD
role: STUDY_CHAIR
affiliation: professor
name: salah s naga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer
name: Mohamed mamdouh Elsayed, MD
role: STUDY_CHAIR
affiliation: Lecturer
name: Mona m tahoun, MD
role: STUDY_CHAIR
affiliation: assistant lecturer
name: ahmed E El-deeb, Master
role: STUDY_CHAIR
References:
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.
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.
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.