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NCT Number: NCT01925235

Analysis of Remote-ischemic Preconditioning Effects on Kidney Function

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.

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Key information

Conditions

Renal Function Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Injury Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ischemic preconditioning

Procedure

Other names: intermittent arm ischemia through 4 cycles of 5-minute inflation and 5-minute deflation of a blood pressure cuff

Primary outcomes

  1. 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

  1. acute kidney injury

    Time frame: 48 hours after TAVI

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

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

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

Acronym: RenPRO-TAVI

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 19, 2013
Registry last updated
Aug 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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