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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Device: RenalGuard system

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group
ACTIVE_COMPARATOR: RenalGuard group	Device: RenalGuard system; Periprocedural intravenous hydration matched to urinary output.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Ulrich Schäfer, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2017
• Primary Completion (ACTUAL): August 16, 2018
• Study Completion (ACTUAL): August 31, 2020

Study Registration Dates

• First Submitted: August 29, 2020
• First Submitted That Met QC Criteria: August 29, 2020
• First Posted (ACTUAL): September 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Acute kidney injury; Transcatheter aortic valve stenosis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: AKI_TAVI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No