Skip to main content
OpenTrials
Completed

NCT Number: NCT01915446

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemia Acute Kidney Injury Cardiovascular Diseases Digestive System Diseases Fatty Acid-Binding Proteins Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Kidney Diseases Male Urogenital Diseases Mesenteric Ischemia Mesenteric Vascular Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Regensburg

Regensburg, Bavaria, 93053, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Regensburg

Other

Registry information

Official study title

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

Acronym: KISMED

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 5, 2013
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.