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Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation

NCT04537325 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2021-03-19

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

RenalGuard system

Periprocedural intravenous hydration matched to urinary output.

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Ulrich Schäfer, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-20
Primary Completion
2018-08-16
Completion
2020-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04537325 on ClinicalTrials.gov