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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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

Keywords

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EVAR endovascular aortic repair acute kidney failure mesenteric ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Professor Hans-Jürgen Schlitt

Prof. Dr. Hans J. Schlitt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Regensburg

Regensburg, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED

PMID: 29973233 (View on PubMed)

Other Identifiers

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KISMED-001

Identifier Type: -

Identifier Source: org_study_id