Effect of Red Wine, White Wine and Beer on Contrast-Medium Induced Acute Kidney Injury

NCT ID: NCT01562925

Last Updated: 2013-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-09-30

Brief Summary

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Patients with impaired renal function are at elevated risk for development of contrast-medium induced acute kidney injury (CI-AKI). CI-AKI is associated with increased risk for cardiovascular morbidity and mortality. Effective CI-AKI prevention strategies are needed.

The RenPro-II-WINE Trial was designed to test the hypothesis whether moderate red wine consumption prior to contrast-medium use is effective in CI-AKI prevention.

Consecutive patients with impaired renal function undergoing elective coronary angiography will be assigned in one of four treatment arms: a. control patients receiving standard care b. patients receiving standard care plus red wine c. patients receiving standard care plus white wine d. patients receiving standard care plus beer This study will give important answers on how to prevent CI-AKI in patients with impaired renal function undergoing contrast media exposure.

Detailed Description

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Conditions

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Chronic Renal Failure/ Kidney Disease Contrast-medium Induced Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Red Wine

Patients assigned to red wine group will receive standard care plus two doses of red wine: the evening before contrast-medium use and the morning of contrast-medium exposure

Group Type ACTIVE_COMPARATOR

Red wine

Intervention Type DIETARY_SUPPLEMENT

Red wine First dosage: 3 ml per kg bodyweight (the evening before contrast medium exposure) Second dosage: 1.5 ml per kg bodyweight (60-120 minutes before contrast medium exposure

White wine

Group Type ACTIVE_COMPARATOR

White wine

Intervention Type DIETARY_SUPPLEMENT

White wine First dosage: 3.3 ml per kg bodyweight (the evening before contrast medium exposure) Second dosage: 1.7 ml per kg bodyweight (60-120 minutes before contrast medium exposure

Beer

Group Type ACTIVE_COMPARATOR

Beer

Intervention Type DIETARY_SUPPLEMENT

Beer First dosage: 7.8 ml per kg bodyweight (the evening before contrast medium exposure) Second dosage: 3.9 ml per kg bodyweight (60-120 minutes before contrast medium exposure

Control

Patients assigned to control group will receive standard care. Patients receive ordinary still water without alcohol the evening before(7.8 ml per kg bodyweight) and 60-120 minutes before contrast exposure (at least 3.9 ml per kg bodyweight)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Red wine

Red wine First dosage: 3 ml per kg bodyweight (the evening before contrast medium exposure) Second dosage: 1.5 ml per kg bodyweight (60-120 minutes before contrast medium exposure

Intervention Type DIETARY_SUPPLEMENT

White wine

White wine First dosage: 3.3 ml per kg bodyweight (the evening before contrast medium exposure) Second dosage: 1.7 ml per kg bodyweight (60-120 minutes before contrast medium exposure

Intervention Type DIETARY_SUPPLEMENT

Beer

Beer First dosage: 7.8 ml per kg bodyweight (the evening before contrast medium exposure) Second dosage: 3.9 ml per kg bodyweight (60-120 minutes before contrast medium exposure

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Frühburgunder 2006, Spätlese Trocken, Schloss Westerhaus, Rheinhessen, 12.5% vol Riesling feinherb 2009, Dr. Willkomm, Bernkastel-Kues, 12.5% vol Cologne mild beer (Kölsch) Gaffel Kölsch, Gaffel Brauerei Cologne, 4.8% vol

Eligibility Criteria

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Inclusion Criteria

* age \>= 18 years
* impaired renal function (baseline estimated glomerular filtration rate of \<60 ml/min)
* at least three of following comorbidities: hypertension, diabetes mellitus without insulin therapy, heart failure NYHA III and/or left ventricular ejection fraction \<35%, peripheral artery disease, coronary artery disease

Exclusion Criteria

* known alcohol addiction
* severe renal impairment (estimated glomerular filtration rate \<15 ml/min and/or in chronic dialysis program
* Recent (\<=30 days) contrast media exposure
* insulin therapy
* Patients enrolled in concomitant studies
* fertile women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Dr. Fikret Er

MD, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Herzzentrum der Universität zu Köln

Cologne, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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RenPro-WINE

Identifier Type: -

Identifier Source: org_study_id

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