Analysis of Remote-ischemic Preconditioning Effects on Kidney Function

Completed

• Conditions: Renal Function; Renal Injury
• Interventions: Procedure: remote ischemic preconditioning

• Registration Number: NCT01925235
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2013-08
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-16
• Last Update Submitted: 2013-08-16
• Study First Posted: 2013-08-19
• Last Update Posted: 2013-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RIPC	remote ischemic preconditioning	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)

Primary Outcome Measures

Name	Time	Method
change in parameters determining renal function and injury	48 hours after TAVI	serum creatinine, cystatin c, urinary neutrophil gelatinase-associated lipocalin (NGAL)

Secondary Outcome Measures

Name	Time	Method
acute kidney injury	48 hours after TAVI	increase in serum creatinine ≥25% or ≥0.5 mg/dL above baseline at 48 hours after TAVI

Trial Locations

Locations (1)

University Hospital of Cologne; 🇩🇪 Cologne, NRW, Germany