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Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
RenalGuard system
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring Transcatheter aortic valve stenosis, Chronic kidney disease, Acute kidney injury

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Medical Center Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

RenalGuard group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 29, 2020
Last Updated
March 18, 2021
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT04537325
Brief Title
Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
August 16, 2018 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Transcatheter aortic valve stenosis, Chronic kidney disease, Acute kidney injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RenalGuard group
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
RenalGuard system
Intervention Description
Periprocedural intravenous hydration matched to urinary output.
Primary Outcome Measure Information:
Title
Acute kidney injury
Description
Increase of serum-creatinine of 0,3 mg/dl in pre-procedural serum-creatinine within 7 days after Transcatheter aortic valve implantation
Time Frame
Within 7 days after Transcatheter aortic valve implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Schäfer, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

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Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation

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