Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Device: RenalGuard system

• Registration Number: NCT04537325
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Study Timeline

• Study Start: 2017-01-20
• Primary Completion: 2018-08-16
• Study First Submitted: 2020-08-29
• Study First Submitted QC: 2020-08-29
• Study Completion: 2020-08-31
• Study First Posted: 2020-09-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation
• Chronic kidney disease (baseline glomerular filtration rate ≤ 60 ml/min)
• Written informed consent

Exclusion Criteria

• Hemodynamic instability
• Dialysis-dependent chronic kidney injury
• Emergency transcatheter aortic valve stenosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RenalGuard group	RenalGuard system	-

Primary Outcome Measures

Name	Time	Method
Acute kidney injury	Within 7 days after Transcatheter aortic valve implantation	Increase of serum-creatinine of 0,3 mg/dl in pre-procedural serum-creatinine within 7 days after Transcatheter aortic valve implantation

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany