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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04537325

Enrollment

Registered

2020-09-03

Start date

2017-01-20

Completion date

2020-08-31

Last updated

2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Transcatheter aortic valve stenosis, Chronic kidney disease, Acute kidney injury

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.

Interventions

DEVICERenalGuard system

Periprocedural intravenous hydration matched to urinary output.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026