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Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery

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ClinicalTrials.gov Identifier: NCT04087161
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
Münster, University Hospital, Department of Vascular Surgery
Berlin, University medicine Charité, Department of Vascular Surgery
Information provided by (Responsible Party):
Alexander Gombert, RWTH Aachen University

Brief Summary:

Assessment of postoperative acute kidney insufficiency according to the KDIGO classification using the Nephrocheck system.

Multicentric, prospective study Open TAAA Repair in 3-4 centers in Germany and Europe


Condition or disease Intervention/treatment
Early Assessment of AKI After TAAA Repair Other: Nephrocheck bed side testing of AKI

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup


Intervention Details:
  • Other: Nephrocheck bed side testing of AKI
    Usage of Nephrocheck system to assess AKI after open TAAA repair


Primary Outcome Measures :
  1. Acute kidney injury after open TAAA repair [ Time Frame: 90 days after surgery ]
    Acute kidney injury defined according to the KDIGO classification and its association with the Nephrocheck assessment results


Secondary Outcome Measures :
  1. Mortality, major adverse events such as any complication [ Time Frame: 90 days after surgery ]
    Any severe adverse Outcome after open TAAA repair and its association with the Nephrocheck assessment results



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing elective, open TAAA repair
Criteria

Inclusion Criteria:

elective open TAAA repai

18-80 years

no pregnancy

Exclusion Criteria:

emergency treatment participation in another Trial renal replacement therapy


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): NCT04087161


Contacts
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Contact: Alexander Gombert, MD 0049-241-8035974 agombert@ukaachen.de

Locations
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Germany
University Hospital RWTH Aachen Recruiting
Aachen, NRW, Germany, 52074
Contact: Alexander Gombert, MD       agombert@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Münster, University Hospital, Department of Vascular Surgery
Berlin, University medicine Charité, Department of Vascular Surgery

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Responsible Party: Alexander Gombert, Prinicipal Investigator, RWTH Aachen University
ClinicalTrials.gov Identifier: NCT04087161     History of Changes
Other Study ID Numbers: 29012015
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases