Clinical trial NCT01915446: Kidney and Intestinal Markers for Early Detection of Organ Injury After Endovascular Aortic Repair
Official title: Kidney and Intestinal Markers for Early Detection of Organ Injury After Endovascular Aortic Repair - The KISMED Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia
Fatty Acid-Binding Proteins
Mesenteric Vascular Disease
Acute Kidney Injury
Keywords: EVAR
endovascular aortic repair
acute kidney failure
mesenteric ischemia
Lead sponsor: University Hospital Regensburg
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing endovascular aortic repair in a University hospital

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.


Eligibility criteria: 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

Primary outcomes:
measure: Level of biomarkers of abdominal organ injury (plasmatic i-FABP, TIMP-2, IGFBP7)
timeFrame: 48hours post surgery
Secondary outcomes:
measure: Local tissue perfusion and microcirculation as quantified by CEUS
timeFrame: 48 hours post surgery
measure: Incidence of acute kidney injury (AKI)
timeFrame: first 48 hours post surgery
measure: Localization and incidence of intestinal ischemia
timeFrame: first 48 hours post surgery
Other outcomes:
measure: Other parameters of postoperative course
timeFrame: in-hospital stay, follow up to 90 days
Locations:
city: Regensburg
country: Germany
facility: University Medical Center Regensburg
state: Bavaria
Study officials:
References:
citation: Gocze I, Ehehalt K, Zeman F, Riquelme P, Pfister K, Graf BM, Bein T, Geissler EK, Kasprzak P, Schlitt HJ, Kellum JA, Hutchinson JA, Eggenhofer E, Renner P. Postoperative cellular stress in the kidney is associated with an early systemic gammadelta T-cell immune cell response. Crit Care. 2018 Jul 4;22(1):168. doi: 10.1186/s13054-018-2094-x.