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

Acute Kidney Injury Clinical Trial

— KISMED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915446
• Other study ID #: KISMED-001
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: December 17, 2014
• Start date: July 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University Hospital Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	University Medical Center Regensburg	Regensburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other parameters of postoperative course	Course of established laboratory markers of hypoperfusion (lactate, creatinine kinase, interleukin 6, C-reactive protein,hemoglobin, central venous oxygen saturation); Standard markers of renal function: serum creatinine (sCr), urine output and estimated glomerular filtration rate (eGFR); Standard Doppler Ultrasound of the kidney vessels and superior mesenteric artery; Assessment of hemodynamics (cumulative dose of inotropic support intraoperatively, at 24h and 48h, cumulative fluid balance at 24h, 48h) or pulmonary failure (Horowitz Index); Frequency and localization of other ischemic conditions, such as limb ischemia and cerebral ischemia; Identification of an "immunological pattern" indicating intestinal ischemia or kidney failure; Severity of illness score SAPS II; Need of renal replacement therapy (RRT) in postoperative course (days); Creatinin level and RRT at discharge; Length of ICU stay and length of hospital stay - 28- days and 90-days mortality	in-hospital stay, follow up to 90 days	No
Primary	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	No
Secondary	Local tissue perfusion and microcirculation as quantified by CEUS		48 hours post surgery	No
Secondary	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	No
Secondary	Localization and incidence of intestinal ischemia		first 48 hours post surgery	No