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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01915446
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
Professor Hans-Jürgen Schlitt, University Hospital Regensburg

Study Description
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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.


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

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Kidney and Intestinal Markers for Early Detection of Organ Injury After Endovascular Aortic Repair - The KISMED Study
Study Start Date : July 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Local tissue perfusion and microcirculation as quantified by CEUS [ Time Frame: 48 hours post surgery ]
  2. 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)

  3. Localization and incidence of intestinal ischemia [ Time Frame: first 48 hours post surgery ]

Other Outcome Measures:
  1. Other parameters of postoperative course [ Time Frame: in-hospital stay, follow up to 90 days ]
    • 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


Biospecimen Retention:   Samples Without DNA
Plasma Urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing endovascular aortic repair in a University hospital
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915446


Locations
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Germany
University Medical Center Regensburg
Regensburg, Bavaria, Germany, 93053
Sponsors and Collaborators
University Hospital Regensburg
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Professor Hans-Jürgen Schlitt, Prof. Dr. Hans J. Schlitt, University Hospital Regensburg
ClinicalTrials.gov Identifier: NCT01915446    
Other Study ID Numbers: KISMED-001
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014
Keywords provided by Professor Hans-Jürgen Schlitt, University Hospital Regensburg:
EVAR
endovascular aortic repair
acute kidney failure
mesenteric ischemia
Additional relevant MeSH terms:
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Acute Kidney Injury
Vascular Diseases
Ischemia
Wounds and Injuries
Pathologic Processes
 Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cardiovascular Diseases