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Effect of Red Wine, White Wine and Beer on Contrast-Medium Induced Acute Kidney Injury (RenPro-II-WINE)

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ClinicalTrials.gov Identifier: NCT01562925
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Fikret Er, University of Cologne

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Renal Failure/ Kidney Disease Contrast-medium Induced Acute Kidney Injury Dietary Supplement: Red wine Dietary Supplement: White wine Dietary Supplement: Beer Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Study for Evaluation of the Impact of Red Wine, White Wine and Beer Intake on Contrast-Medium Induced Acute Kidney Injury
Study Start Date : March 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Active Comparator: 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
Dietary Supplement: 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
Other Name: Frühburgunder 2006, Spätlese Trocken, Schloss Westerhaus, Rheinhessen, 12.5% vol

Active Comparator: White wine 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
Other Name: Riesling feinherb 2009, Dr. Willkomm, Bernkastel-Kues, 12.5% vol

Active Comparator: Beer 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
Other Names:
  • Cologne mild beer (Kölsch)
  • Gaffel Kölsch, Gaffel Brauerei Cologne, 4.8% vol

No Intervention: 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)



Primary Outcome Measures :
  1. CI-AKI incidence [ Time Frame: <48 hours after contrast-medium exposure ]
    Increment of serum-creatinin of 0.5 mg/dl or of at least 25% in 48 hours after contrast medium intake from baseline.


Secondary Outcome Measures :
  1. Biomarkers assessing acute kidney injury [ Time Frame: <48 hours ]
    Changes of urinary neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562925


Locations
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Germany
Herzzentrum der Universität zu Köln
Cologne, Germany, 50937
Sponsors and Collaborators
University of Cologne
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Responsible Party: Dr. Fikret Er, MD, Assistant Professor, University of Cologne
ClinicalTrials.gov Identifier: NCT01562925    
Other Study ID Numbers: RenPro-WINE
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: July 8, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Kidney Diseases
Acute Kidney Injury
Kidney Failure, Chronic
Wounds and Injuries
Urologic Diseases
Renal Insufficiency
Renal Insufficiency, Chronic