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

N/ACompletedNCT01915446

University Hospital Regensburg20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 48hours post surgery

Secondary Outcomes

Local tissue perfusion and microcirculation as quantified by CEUS

Time frame: 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)

Time frame: first 48 hours post surgery

Localization and incidence of intestinal ischemia