Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-20

Study Completion Date

2020-08-31

Brief Summary

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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.

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Detailed Description

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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

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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RenalGuard group

Group Type ACTIVE_COMPARATOR

RenalGuard system

Intervention Type DEVICE

Periprocedural intravenous hydration matched to urinary output.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RenalGuard system

Periprocedural intravenous hydration matched to urinary output.

Intervention Type DEVICE

Eligibility Criteria

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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