NCT01915446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

1.3 years

First QC Date

July 31, 2013

Last Update Submit

December 17, 2014

Conditions

IschemiaFatty Acid-Binding ProteinsMesenteric Vascular DiseaseAcute Kidney Injury

Keywords

EVARendovascular aortic repairacute kidney failuremesenteric ischemia

Outcome Measures

Primary Outcomes (1)

  • Level of biomarkers of abdominal organ injury (plasmatic i-FABP, TIMP-2, IGFBP7)

    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.

    48hours post surgery

Secondary Outcomes (3)

  • Local tissue perfusion and microcirculation as quantified by CEUS

    48 hours post surgery

  • Incidence of acute kidney injury (AKI)

    first 48 hours post surgery

  • Localization and incidence of intestinal ischemia

    first 48 hours post surgery

Other Outcomes (1)

  • Other parameters of postoperative course

    in-hospital stay, follow up to 90 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing endovascular aortic repair in a University hospital

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)
  • Anemia with hemoglobin concentration \< 7g/dl
  • Patients \< 18 years of age
  • Patients not able to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29973233DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma Urine

MeSH Terms

Conditions

IschemiaAcute Kidney InjuryMesenteric Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPeritoneal DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Hans J. Schlitt

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 5, 2013

Study Start

July 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

DE(1)