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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087161
• Other study ID #: 29012015
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2024
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Early Assessment of AKI After TAAA Repair

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital RWTH Aachen	Aachen	NRW

Sponsors (3)

Lead Sponsor	Collaborator
RWTH Aachen University	Berlin, University medicine Charité, Department of Vascular Surgery, Münster, University Hospital, Department of Vascular Surgery

Country where clinical trial is conducted

Germany, 

Outcome

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