Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006461

Trial Description

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Title

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

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Trial Acronym

KISMED

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006461
  •   2015/04/30
  •   2013/07/31
  •   yes
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Secondary IDs

  •   NCT01915446  (ClinicalTrials.gov)
  •   KISMED-001  (University Hospital Regensburg)
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Health Condition or Problem studied

  •   Ischemia
  •   Fatty Acid-Binding Proteins
  •   Mesenteric Vascular Disease
  •   Acute Kidney Injury
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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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.

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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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2013/07/31
  •   100
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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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

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Addresses

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    • University Hospital Regensburg
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    • Ivan Goecze, MD 
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    • Ivan Goecze, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.