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Analysis of Remote-ischemic Preconditioning Effects on Kidney Function (RenPRO-TAVI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01925235
First Posted: August 19, 2013
Last Update Posted: August 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Fikret Er, University of Cologne
  Purpose

Patients with impaired renal function are at elevated risk for development of acute kidney injury (AKI). AKI is associated with increased risk for cardiovascular morbidity and mortality. Effective AKI prevention strategies are needed. Remote ischemic preconditioning (RIPC) is a novel and successful strategy to attenuate contrast medium induced AKI in patients undergoing elective coronary angiography.

The retrospective RenPro-TAVI Trial was designed to test the hypothesis whether remote ischemic preconditioning might attenuate kidney injury in patients receiving transcatheter aortic valve implantation (TAVI).

Patients with impaired renal function undergoing TAVI will be evaluated in respect whether they received remote ischemic preconditioning before the procedure or not. This study will give insight if RIPC might be beneficial in these patients.


Condition Intervention
Renal Function Renal Injury Procedure: remote ischemic preconditioning

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Remote Ischemic Preconditioning Effects on Kidney Function in Patients Receiving Transcatheter Aortic Valve Implantation

Resource links provided by NLM:


Further study details as provided by Dr. Fikret Er, University of Cologne:

Primary Outcome Measures:
  • change in parameters determining renal function and injury [ Time Frame: 48 hours after TAVI ]
    serum creatinine, cystatin c, urinary neutrophil gelatinase-associated lipocalin (NGAL)


Secondary Outcome Measures:
  • acute kidney injury [ Time Frame: 48 hours after TAVI ]
    increase in serum creatinine ≥25% or ≥0.5 mg/dL above baseline at 48 hours after TAVI


Enrollment: 18
Study Start Date: March 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Control
patients with impaired renal function and a high risk of developing acute kidney injury undergoing TAVI and receiving standard care including pre-hydration 12 hours prior and 12 hours post procedure
RIPC
patients with impaired renal function and a high risk of developing acute kidney injury undergoing TAVI and receiving standard care including pre-hydration 12 hours prior and 12 hours post procedure plus ischemic preconditioning (intermittent arm ischemia through 4 cycles of 5-minute inflation and 5-minute deflation of a blood pressure cuff)
Procedure: remote ischemic preconditioning
Other Name: intermittent arm ischemia through 4 cycles of 5-minute inflation and 5-minute deflation of a blood pressure cuff

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with impaired renal function and a high risk of developing contrast medium-induced acute kidney injury undergoing TAVI
Criteria

Inclusion Criteria:

  • age >= 18 years
  • impaired renal function (baseline eGFR of <60 ml/min)
  • high INTEGER risk score > 11
  • high EuroSCORE (European system for cardiac operative risk evaluation)

Exclusion Criteria:

  • severe renal impairment (eGFR <15 ml/min and/or in chronic dialysis)
  • recent (<=30 days) contrast media exposure
  • patients enrolled in concomitant studies
  • fertile women
  Contacts and Locations
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): NCT01925235


Locations
Germany
University Hospital of Cologne
Cologne, NRW, Germany, 50931
Sponsors and Collaborators
University of Cologne