NCT04537325

Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation

Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation in Patients With Chronic Kidney Disease With Controlled Intravenous Hydration Matched to Urinary Output

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Randomized controlled, single-center trial randomizing patients with chronic kidney disease and symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). Patients are randomized in a 1:1 ratio to periprocedural intravenous hydration matched to urine output using the RenalGuard system and to standard hydration. The purpose of the study is to test, wether the controlled intravenous hydration with the RenalGuard system is superior to standard hydration to prevent acute kidney injury after TAVI.

Detailed description

Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is associated with worse outcome. The RenalGuard system was developed to prevent AKI by a controlled furosemide-induced diuresis with matched isotonic intravenous hydration. It is based on the theory, that a high urinary output prevents contrast media-induced nephropathy (CIN). The present study is a prospective, randomized trial to investigate wether a matched intravenous hydration using the RenalGuard system is superior to standard pre- and postprocedural intravenous hydration in patients with severe aortic valve stenosis and chronic kidney disease undergoing TAVI. Primary endpoint is the occurrence of AKI after TAVI.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DEVICE	RenalGuard system	Periprocedural intravenous hydration matched to urinary output.

Timeline

• Start date: 2017-01-20
• Primary completion: 2018-08-16
• Completion: 2020-08-31
• First posted: 2020-09-03
• Last updated: 2021-03-19

Locations

1 site across 1 country: Germany