Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation

NCT04537325 | Completed

• 1 other identifier: AKI_TAVI
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Transcatheter aortic valve stenosis; Chronic kidney disease; Acute kidney injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

RenalGuard group

ACTIVE COMPARATOR

Device: RenalGuard system

Control group

NO INTERVENTION

Interventions

RenalGuard system DEVICE

Periprocedural intravenous hydration matched to urinary output.

RenalGuard group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation
• Chronic kidney disease (baseline glomerular filtration rate ≤ 60 ml/min)
• Written informed consent

You may not qualify if:

• Hemodynamic instability
• Dialysis-dependent chronic kidney injury
• Emergency transcatheter aortic valve stenosis

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (2)

• Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.

  PMID: 39878152 DERIVED

• Voigtlander-Buschmann L, Schafer S, Schmidt-Lauber C, Weimann J, Shenas M, Giraldo Cortes J, Kuta PM, Zeller T, Twerenbold R, Seiffert M, Schofer N, Schneeberger Y, Schafer A, Schirmer J, Reichenspurner H, Blankenberg S, Conradi L, Schafer U. Effect of periprocedural furosemide-induced diuresis with matched isotonic intravenous hydration in patients with chronic kidney disease undergoing transcatheter aortic valve implantation. Clin Res Cardiol. 2024 Jun;113(6):801-811. doi: 10.1007/s00392-023-02234-z. Epub 2023 Jun 1.

  PMID: 37264143 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulrich Schäfer, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 3, 2020
• Study Start: January 20, 2017
• Primary Completion: August 16, 2018
• Study Completion: August 31, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

DE (1)