Clinical trial NCT01925235: Analysis of Remote-ischemic Preconditioning Effects on Kidney Function
Official title: Remote Ischemic Preconditioning Effects on Kidney Function in Patients Receiving Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Function
Renal Injury
Keywords: remote ischemic preconditioning
acute kidney injury
TAVI
RenPRO trial
parameters
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2013-08-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in parameters determining renal function and injury
timeFrame: 48 hours after TAVI
Secondary outcomes:
measure: acute kidney injury
timeFrame: 48 hours after TAVI
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: NRW
Study officials:
References:
citation: 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.
citation: 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.