Kidney and Intestinal Markers for Early Detection of Organ Injury After Endovascular Aortic Repair

Study Overview
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Brief Summary
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This study aims to investigate the predictive value of novel biomarkers and contrast-enhanced ultrasonography for early detection of abdominal end-organ (kidney and intestinum) hypoperfusion and ischemia in patients undergoing endovascular aortic repair (EVAR) for aortic aneurysm or dissection. In this context, patients will be monitored for renal biomarkers (TIMP-2, IGFBP7) and intestinal biomarkers (plasmatic intestinal fatty acid binding protein (i-FABP)) and local tissue perfusion will be assessed using contrast-enhanced ultrasonography (CEUS). The ultimate goal of this study is an early identification of patients developing one or both of these complications, which may facilitate a timely intervention to improve outcome.

Official Title
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Kidney and Intestinal Markers for Early Detection of Organ Injury After Endovascular Aortic Repair - The KISMED Study

Conditions
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Ischemia, Fatty Acid-Binding Proteins, Mesenteric Vascular Disease, Acute Kidney Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Existence of an aortic aneurysm with need of repair as indicated by the treating vascular surgeon Aortic stenting involving the origin of both mesenteric (i.e. superior and inferior mesenteric arteries) and kidney arteries Central line is present to perform repeated blood collections Written informed consent is obtained. Exclusion Criteria: Pre-existing severe liver or kidney injury (defined as spontaneous international normalized ratio (INR) >2 or creatinine >2 mg/dl or renal-replacement therapy in the pre-operative course.) Known allergy to ultrasound contrast media (exclusion for the CEUS but not for marker evaluation) Anemia with hemoglobin concentration < 7g/dl Patients < 18 years of age Patients not able to give written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of biomarkers of abdominal organ injury (plasmatic i-FABP, TIMP-2, IGFBP7) | The primary objective of this study is to evaluate the early post-operative course of kidney and intestinal biomarkers in patients following EVAR and their value for prediction of development of acute kidney injury or acute mesenteric ischemia. | 48hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tissue perfusion and microcirculation as quantified by CEUS |  | 48 hours post surgery | 
| Incidence of acute kidney injury (AKI) | Incidence of AKI within the first 48 hours as based on current KDIGO/AKIN recommendation (Kidney Disease Improving Global Outcomes - Clinical Practice Guideline for Acute Kidney Injury) | first 48 hours post surgery | 
| Localization and incidence of intestinal ischemia |  | first 48 hours post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EVAR, endovascular aortic repair, acute kidney failure, mesenteric ischemia