Analysis of Remote-ischemic Preconditioning Effects on Kidney Function

Renal Function Clinical Trial

— RenPRO-TAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925235
• Other study ID #: Ren-PRO TAVI retro
• Status: Completed
• Phase: N/A
• First received: August 15, 2013
• Last updated: August 16, 2013
• Start date: March 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2013
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Renal Function
• Renal Injury

Intervention

Procedure:
• remote ischemic preconditioning

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in parameters determining renal function and injury	serum creatinine, cystatin c, urinary neutrophil gelatinase-associated lipocalin (NGAL)	48 hours after TAVI	No
Secondary	acute kidney injury	increase in serum creatinine =25% or =0.5 mg/dL above baseline at 48 hours after TAVI	48 hours after TAVI	No