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

University of Cologne

Status: Completed

Conditions: Renal Function; Renal Injury

Treatments: Procedure: remote ischemic preconditioning

Study type: Observational

Funder types: Other

Identifiers

NCT01925235

Ren-PRO TAVI retro

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

18 participants in 2 patient groups

Control

Description:

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

Description:

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)

Treatment:

Procedure: remote ischemic preconditioning