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

Sponsor
University of Cologne (Other)
Overall Status
Completed
CT.gov ID
NCT01562925
Collaborator
(none)
260
Enrollment
1
Location
4
Arms
6
Duration (Months)
43
Patients Per Site Per Month

Study Details

Study Description

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

  1. 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
  • Dietary Supplement: Red wine
  • Dietary Supplement: White wine
  • Dietary Supplement: Beer
 Phase 3

Study Design

Study Type:
Interventional
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 :
Mar 1, 2012
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

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 Names:
  • 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 Names:
  • 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)

    Outcome Measures

    Primary Outcome Measures

    1. CI-AKI incidence [<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 [<48 hours]

      Changes of urinary neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Herzzentrum der Universität zu Köln Cologne Germany 50937

    Sponsors and Collaborators

    • University of Cologne

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Fikret Er, MD, Assistant Professor, University of Cologne
    ClinicalTrials.gov Identifier:
    NCT01562925
    Other Study ID Numbers:
    • RenPro-WINE
    First Posted:
    Mar 26, 2012
    Last Update Posted:
    Jul 8, 2013
    Last Verified:
    Jul 1, 2013
    Additional relevant MeSH terms:
    Kidney Diseases
    Acute Kidney Injury
    Kidney Failure, Chronic
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 8, 2013