Remote Ischemic Preconditioning Effects on Kidney Function in Patients Receiving Transcatheter Aortic Valve Implantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Cologne
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- change in parameters determining renal function and injury
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Dr. Fikret Er
Associate Professor
University of Cologne