Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery
April 9, 2024 updated by: Alexander Gombert, RWTH Aachen University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
-
Aachen, NRW, Germany, 52074
- University Hospital RWTH Aachen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Patients undergoing elective, open TAAA repair
Description
Inclusion Criteria:
elective open TAAA repai
18-80 years
no pregnancy
Exclusion Criteria:
emergency treatment participation in another Trial renal replacement therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
90 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
90 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2019
Primary Completion (Actual)
April 25, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
September 10, 2019
First Submitted That Met QC Criteria
September 10, 2019
First Posted (Actual)
September 12, 2019
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29012015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.