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NCT04537325 Clinical Trial

Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04537325
Other study ID # AKI_TAVI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2017
Est. completion date August 31, 2020

Study information
Verified date March 2021
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date August 31, 2020
Est. primary completion date August 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• RenalGuard system
Periprocedural intravenous hydration matched to urinary output.

Locations
Country Name City State
Germany University Medical Center Hamburg-Eppendorf Hamburg

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute kidney injury Increase of serum-creatinine of 0,3 mg/dl in pre-procedural serum-creatinine within 7 days after Transcatheter aortic valve implantation Within 7 days after Transcatheter aortic valve implantation
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