Analysis of Remote-ischemic Preconditioning Effects on Kidney Function

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Function, Renal Injury

Intervention / Treatment
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* Procedure: remote ischemic preconditioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>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<br>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<br> <br> * Other names: intermittent arm ischemia through 4 cycles of 5-minute inflation and 5-minute deflation of a blood pressure cuff;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in parameters determining renal function and injury | serum creatinine, cystatin c, urinary neutrophil gelatinase-associated lipocalin (NGAL) | 48 hours after TAVI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute kidney injury | increase in serum creatinine ≥25% or ≥0.5 mg/dL above baseline at 48 hours after TAVI | 48 hours after TAVI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote ischemic preconditioning, acute kidney injury, TAVI, RenPRO trial, parameters