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

Completed

• Conditions: Acute Kidney Injury; Fatty Acid-Binding Proteins; Ischemia; Mesenteric Vascular Disease

• Registration Number: NCT01915446
• Lead Sponsor: University Hospital Regensburg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-05
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of biomarkers of abdominal organ injury (plasmatic i-FABP, TIMP-2, IGFBP7)	48hours post surgery	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of acute kidney injury (AKI)	first 48 hours post surgery	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)
Local tissue perfusion and microcirculation as quantified by CEUS	48 hours post surgery
Localization and incidence of intestinal ischemia	first 48 hours post surgery

Trial Locations

Locations (1)

University Medical Center Regensburg; 🇩🇪 Regensburg, Bavaria, Germany