Analysis of Remote-ischemic Preconditioning Effects on Kidney Function

N/ACompletedNCT01925235

University of Cologne18 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Renal Function Renal Injury

Interventions

remote ischemic preconditioningPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

serum creatinine, cystatin c, urinary neutrophil gelatinase-associated lipocalin (NGAL)

Time frame: 48 hours after TAVI

Secondary Outcomes

acute kidney injury

increase in serum creatinine ≥25% or ≥0.5 mg/dL above baseline at 48 hours after TAVI