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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:
Sponsor: University Hospital Regensburg

Current Primary Outcome: Level of biomarkers of abdominal organ injury (plasmatic i-FABP, TIMP-2, IGFBP7) [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Local tissue perfusion and microcirculation as quantified by CEUS [ Time Frame: 48 hours post surgery ]
  • Incidence of acute kidney injury (AKI) [ Time Frame: 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)
  • Localization and incidence of intestinal ischemia [ Time Frame: first 48 hours post surgery ]


Original Secondary Outcome: Same as current

Information By: University Hospital Regensburg

Dates:
Date Received: July 31, 2013
Date Started: July 2013
Date Completion:
Last Updated: December 17, 2014
Last Verified: December 2014