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Clinical Trials/NCT01925235
NCT01925235
Completed
Not Applicable

Remote Ischemic Preconditioning Effects on Kidney Function in Patients Receiving Transcatheter Aortic Valve Implantation

University of Cologne1 site in 1 country18 target enrollmentMarch 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Function
Sponsor
University of Cologne
Enrollment
18
Locations
1
Primary Endpoint
change in parameters determining renal function and injury
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
July 2011
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Fikret Er

Associate Professor

University of Cologne

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • acute kidney injury(48 hours after TAVI)

Study Sites (1)

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