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The Effect of the Forced Diuresis With Matched Hydration in Reducing Acute Kidney Injury During TAVI (REDUCE-AKI)

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ClinicalTrials.gov Identifier: NCT01866800
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

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).

Condition or disease Intervention/treatment Phase
Radiographic Contrast Agent Nephropathy Aortic Valve Stenosis With Insufficiency Device: Renal Guard Drug: Conventional Treatment Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Reducing Acute Kidney Injury in TAVI Patients (REDUCE Trial)
Actual Study Start Date : June 1, 2013
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : May 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Renal Guard
Renal Guard in addition to Saline and N-Acetylcysteine
Device: Renal Guard
Renal Guard

Drug: Conventional Treatment
Saline and N-acetylcysteine

Placebo Comparator: Conventional Treatment
Saline and N-Acetylcysteine
Drug: Conventional Treatment
Saline and N-acetylcysteine




Primary Outcome Measures :
  1. Reduction of acute kidney injury (stage 1 or above) at 48-72 hours. [ Time Frame: 48-72 hours ]
    we will measure the incidence of VARC-2 acute kidney injury at 48-72 hours.


Secondary Outcome Measures :
  1. whether endothelial function assessment can predict AKI AKI. [ Time Frame: 2 years ]
    evaluate whether endothelial dysfunction can predict AKI

  2. Prevention of AKI according to chronic statin treatment [ Time Frame: 2 years ]
    we will compare patients with and without statin treatment for the incidence of AKI

  3. Predictive power of abnormal carotid doppler results and AKI incidence [ Time Frame: 2 years ]
    We will evaluate the prognostic ability of carotid doppler for predicting AKI

  4. Predictive power of different biomarkers for predicting AKI and outcome [ Time Frame: 2 years ]
    We will evaluate inflammatory, metabolic and neuroendocrine biomarkers

  5. 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. [ Time Frame: 2 years ]
  6. the RenalGuard system will lower 30 day readmission rate [ Time Frame: 2 years ]
  7. the RenalGuard system can lower 30 day congestive heart failure exacerbation rate [ Time Frame: 2 years ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866800


Locations
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Israel
Tel Aviv Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Shmuel Banai, Prof. Tel Aviv Sourasky MC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: michal roll, VPRD, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01866800    
Other Study ID Numbers: 0111-13
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
TAVI
TAVR
CIN
AKI
Additional relevant MeSH terms:
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Acute Kidney Injury
Aortic Valve Stenosis
Kidney Diseases
Urologic Diseases
Renal Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction