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

University Hospital Regensburg

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01915446

KISMED-001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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