Early Assessment of AKI After TAAA Repair Clinical Trial
Official title:
Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery
NCT number | NCT04087161 |
Other study ID # | 29012015 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2019 |
Est. completion date | December 30, 2022 |
Verified date | April 2024 |
Source | RWTH Aachen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 40 |
Est. completion date | December 30, 2022 |
Est. primary completion date | April 25, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: elective open TAAA repai 18-80 years no pregnancy Exclusion Criteria: emergency treatment participation in another Trial renal replacement therapy |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital RWTH Aachen | Aachen | NRW |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University | Berlin, University medicine Charité, Department of Vascular Surgery, Münster, University Hospital, Department of Vascular Surgery |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute kidney injury after open TAAA repair | Acute kidney injury defined according to the KDIGO classification and its association with the Nephrocheck assessment results | 90 days after surgery | |
Secondary | Mortality, major adverse events such as any complication | Any severe adverse Outcome after open TAAA repair and its association with the Nephrocheck assessment results | 90 days after surgery |