Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation

U

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Conditions

Acute Kidney Injury

Treatments

Device: RenalGuard system

Study type

Interventional

Funder types

Other

Identifiers

NCT04537325
AKI_TAVI

Details and patient eligibility

About

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.

Full 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.

Enrollment

98 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

98 participants in 2 patient groups

RenalGuard group
Active Comparator group
Treatment:
Device: RenalGuard system
Control group
No Intervention group

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems