Renal Cell Arrest and Damage Biomarkers in Progression and Outcome of Septic AKI
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: septic AKI patients 80 patients with sepsis associated AKI stage 1 or 2 according to KDIGO definition |
Diagnostic Test: renal cell arrest and damage biomarkers assessment
measurement of TIMP2 and IGFBP7, KIM-1
|
Outcome Measures
Primary Outcome Measures
- Urinary TIMP2 and IGFBP7 estimation [90 days]
both will be measured by the ELISA technique
- Urinary KIM-1 estimation [90 days]
will be measured by the ELISA technique
- Examination of urine sediment [7 days]
by calculating Perazella score
- progression of AKI [90 days]
by assessing change in eGFR
- Examination of urine sediment [7 days]
by calculating Chawla score
Secondary Outcome Measures
- need for renal replacement therapy [90 days]
need of any dialysis modality
- mortality [90 days]
death
- length of ICU and hospital stay [90 days]
duration of stay
Eligibility Criteria
Criteria
Inclusion Criteria:
-
AKI stage 1 or 2 according to KDIGO definition.
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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:
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Age less than 18 years.
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Patients with pre-existing chronic kidney disease (eGFR<60 ml/min/1.73m2).
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Previous renal replacement therapy.
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Acute kidney injury caused by permanent postrenal obstruction.
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Pregnancy.
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Hepatorenal syndrome.
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Renal transplant recipients.
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Patients for whom survival to 30 days is unlikely due to end stage disease (end stage liver or heart disease or untreatable malignancy).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Medicine, Aexandria University | Alexandria | Egypt | 21526 |
Sponsors and Collaborators
- Alexandria University
Investigators
- Study Chair: Hala S ElWakil, MD, professor
- Principal Investigator: salah s naga, MD, professor
- Study Chair: Mohamed mamdouh Elsayed, MD, Lecturer
- Study Chair: Mona m tahoun, MD, Lecturer
- Study Chair: ahmed E El-deeb, Master, assistant lecturer
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- markers of septic AKI