NCT01925235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
Last Updated

August 19, 2013

Status Verified

August 1, 2013

Enrollment Period

1.3 years

First QC Date

August 15, 2013

Last Update Submit

August 16, 2013

Conditions

Renal FunctionRenal Injury

Keywords

remote ischemic preconditioningacute kidney injuryTAVIRenPRO trialparameters

Outcome Measures

Primary Outcomes (1)

  • change in parameters determining renal function and injury

    serum creatinine, cystatin c, urinary neutrophil gelatinase-associated lipocalin (NGAL)

    48 hours after TAVI

Secondary Outcomes (1)

  • acute kidney injury

    48 hours after TAVI

Study Arms (2)

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

Interventions

remote ischemic preconditioningPROCEDURE
Also known as: intermittent arm ischemia through 4 cycles of 5-minute inflation and 5-minute deflation of a blood pressure cuff
RIPC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Related Publications (2)

  • 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.

    PMID: 22735306BACKGROUND

  • 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.

    PMID: 23662313BACKGROUND

Related Links

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Inflation, Economic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and Organizations

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 15, 2013

First Posted

August 19, 2013

Study Start

March 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 19, 2013

Record last verified: 2013-08

Locations

DE(1)