NCT01866800

Brief Summary

Evaluating whether forced diuresis with matched hydration will reduce the risk of contrast induced nephropathy in patients undergoing Transcatheter Aortic Valve Implantation (TAVI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2019

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

5.8 years

First QC Date

April 30, 2013

Last Update Submit

May 22, 2019

Conditions

Radiographic Contrast Agent NephropathyAortic Valve Stenosis With Insufficiency

Keywords

TAVITAVRCINAKI

Outcome Measures

Primary Outcomes (1)

  • Reduction of acute kidney injury (stage 1 or above) at 48-72 hours.

    we will measure the incidence of VARC-2 acute kidney injury at 48-72 hours.

    48-72 hours

Secondary Outcomes (7)

  • whether endothelial function assessment can predict AKI AKI.

    2 years

  • Prevention of AKI according to chronic statin treatment

    2 years

  • Predictive power of abnormal carotid doppler results and AKI incidence

    2 years

  • Predictive power of different biomarkers for predicting AKI and outcome

    2 years

  • Whether the RenalGuard system can lower major adverse clinical events (MACE) defined as a composite of all-cause mortality, myocardial infarction, AKI, 30 day readmission rate, and dialysis.

    2 years

  • +2 more secondary outcomes

Study Arms (2)

Renal Guard

ACTIVE COMPARATOR

Renal Guard in addition to Saline and N-Acetylcysteine

Device: Renal GuardDrug: Conventional Treatment

Conventional Treatment

PLACEBO COMPARATOR

Saline and N-Acetylcysteine

Drug: Conventional Treatment

Interventions

Renal GuardDEVICE

Renal Guard

Renal Guard
Conventional TreatmentDRUG

Saline and N-acetylcysteine

Conventional TreatmentRenal Guard

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subject is 65 years old who is able and willing to give an informed consent.
  • Patients undergoing planned trans-femoral TAVI.
  • Calculated eGFR below 60ml/min/1.73m2 (MDRD)

You may not qualify if:

  • History of acute coronary syndrome in the past 30 days.
  • History of congesting heart failure with left ventricular ejection fraction \<30% or exacerbation in the past 30 days.
  • Current dialysis treatment.
  • Known furosemide hypersensitivity.
  • Contraindications to placement of a Foley catheter in the bladder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Related Publications (3)

  • 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: 39878152DERIVED

  • Arbel Y, Ben-Assa E, Puzhevsky D, Litmanowicz B, Galli N, Chorin E, Halkin A, Sadeh B, Konigstein M, Bassat OK, Steinvil A, Bazan S, Banai S, Finkelstein A. Forced diuresis with matched hydration during transcatheter aortic valve implantation for Reducing Acute Kidney Injury: a randomized, sham-controlled study (REDUCE-AKI). Eur Heart J. 2019 Oct 7;40(38):3169-3178. doi: 10.1093/eurheartj/ehz343.

    PMID: 31120108DERIVED

  • Arbel Y, Ben-Assa E, Halkin A, Keren G, Schwartz AL, Havakuk O, Leshem-Rubinow E, Konigstein M, Steinvil A, Abramowitz Y, Finkelstein A, Banai S. Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial. Trials. 2014 Jul 2;15:262. doi: 10.1186/1745-6215-15-262.

    PMID: 24986373DERIVED

Study Officials

  • Shmuel Banai, Prof.

    Tel Aviv Sourasky MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
VPRD

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 31, 2013

Study Start

June 1, 2013

Primary Completion

April 1, 2019

Study Completion

May 22, 2019

Last Updated

May 23, 2019

Record last verified: 2019-05

Locations

IL(1)