Analysis of Remote-ischemic Preconditioning Effects on Kidney Function
NCT ID: NCT01925235
Last Updated: 2013-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
18 participants
OBSERVATIONAL
2010-03-31
2011-07-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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)
remote ischemic preconditioning
Interventions
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remote ischemic preconditioning
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* recent (\<=30 days) contrast media exposure
* patients enrolled in concomitant studies
* fertile women
18 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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Dr. Fikret Er
Associate Professor
Locations
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University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany
Countries
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References
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Er F, Nia AM, Dopp H, Hellmich M, Dahlem KM, Caglayan E, Kubacki T, Benzing T, Erdmann E, Burst V, Gassanov N. Ischemic preconditioning for prevention of contrast medium-induced nephropathy: randomized pilot RenPro Trial (Renal Protection Trial). Circulation. 2012 Jul 17;126(3):296-303. doi: 10.1161/CIRCULATIONAHA.112.096370. Epub 2012 Jun 26.
Er F, Nia AM, Dopp H, Dahlem KM, Caglayan E, Erdmann E, Gassanov N, Hellmich M, Burst V, Kubacki T, Benzing T. Response to letter regarding article, "Ischemic preconditioning for prevention of contrast medium-induced nephropathy: randomized Pilot RenPro-Trial (Renal Protection Trial)". Circulation. 2013 Apr 2;127(13):e536. doi: 10.1161/circulationaha.112.147587. No abstract available.
Related Links
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Related Info
Other Identifiers
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Ren-PRO TAVI retro
Identifier Type: -
Identifier Source: org_study_id