Longterm Follow-up After Remote Ischemic Preconditioning for Prevention of Contrast-induced Nephropathy (RenProLong)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Dr. Fikret Er, University of Cologne

ClinicalTrials.gov Identifier:

NCT01760031

First received: December 28, 2012

Last updated: NA

Last verified: December 2012

History: No changes posted

Purpose

Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney injury in patients undergoing elective coronary angiography. This study was designed to acquire long-term data of initially randomized patients in the RenPro Trial.

Condition	Intervention
Impaired Renal Function	Other: Ischemic preconditioning

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Remote Preconditioning for Contrast-Induced Acute Kidney Injury: Long-Term Follow up (RenPro Longterm)

Further study details as provided by University of Cologne:

Primary Outcome Measures:

MACCE [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
Major Adverse Cardiac and Cerebrovascular Events (Combined primary endpoint):

All-cause mortality, cardiovascular mortality, rehospitalization, stroke, myocardial infarction, hemodialysis

Secondary Outcome Measures:

Renal function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
changes of serum creatinine, eGFR, NGAL and cystatin C compared to baseline in both groups.

Estimated Enrollment:	81
Study Start Date:	July 2012
Estimated Study Completion Date:	January 2013
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Subjects with impaired renal function Subjects with baseline impaired renal function undergoing cardiac catheterization with contrast-medium exposure	Other: Ischemic preconditioning Subjects received ischemic preconditioning previous to cardiac catheterization

Detailed Description:

Data of the RenPro Trial has been already published. In the present study data of longterm follow up are collected.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients refered for elective cardiac catherization to the university hospital of Cologne. All patients who participated to the RenPro trial (www.germanctr.de; DRKS-ID DRKS00000666)

Criteria

All patients who participated to the RenPro trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760031

Locations

Germany
University of Cologne
Cologne, NRW, Germany, 50937

Sponsors and Collaborators

University of Cologne

Investigators

Principal Investigator:

Fikret Er, MD

University Hospital of Cologne

More Information

Publications:

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.

Responsible Party:	Dr. Fikret Er, Assistant Professor, University of Cologne
ClinicalTrials.gov Identifier:	NCT01760031 History of Changes
Other Study ID Numbers:	RenPro1L
Study First Received:	December 28, 2012
Last Updated:	December 28, 2012
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Cologne:

preconditioning
contrast-induced acute kidney injury
renal faliure

Additional relevant MeSH terms:

Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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