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

August 16, 2013 updated by: Dr. Fikret Er, University of Cologne

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50931
        • University Hospital of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with impaired renal function and a high risk of developing contrast medium-induced acute kidney injury undergoing TAVI

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
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
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
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in parameters determining renal function and injury
Time Frame: 48 hours after TAVI
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
Time Frame: 48 hours after TAVI
increase in serum creatinine ≥25% or ≥0.5 mg/dL above baseline at 48 hours after TAVI
48 hours after TAVI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (Estimate)

August 19, 2013

Study Record Updates

Last Update Posted (Estimate)

August 19, 2013

Last Update Submitted That Met QC Criteria

August 16, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ren-PRO TAVI retro

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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