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Analysis of Remote-ischemic Preconditioning Effects on Kidney Function

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01925235
Acronym
RenPRO-TAVI
Enrollment
18
Registered
2013-08-19
Start date
2010-03-31
Completion date
2011-07-31
Last updated
2013-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Function, Renal Injury

Keywords

remote ischemic preconditioning, acute kidney injury, TAVI, RenPRO trial, parameters

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.

Interventions

PROCEDUREremote ischemic preconditioning

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in parameters determining renal function and injury48 hours after TAVIserum creatinine, cystatin c, urinary neutrophil gelatinase-associated lipocalin (NGAL)

Secondary

MeasureTime frameDescription
acute kidney injury48 hours after TAVIincrease in serum creatinine ≥25% or ≥0.5 mg/dL above baseline at 48 hours after TAVI

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026