Effect of Red Wine, White Wine and Beer on Contrast-Medium Induced Acute Kidney Injury (RenPro-II-WINE)
Primary Purpose
Chronic Renal Failure/ Kidney Disease, Contrast-medium Induced Acute Kidney Injury
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Red wine
White wine
Beer
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Renal Failure/ Kidney Disease
Eligibility 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
Sites / Locations
- Herzzentrum der Universität zu Köln
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
Red Wine
White wine
Beer
Control
Arm Description
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
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)
Outcomes
Primary Outcome Measures
CI-AKI incidence
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
Biomarkers assessing acute kidney injury
Changes of urinary neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01562925
Brief Title
Effect of Red Wine, White Wine and Beer on Contrast-Medium Induced Acute Kidney Injury
Acronym
RenPro-II-WINE
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 Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Data Monitoring Committee
Yes
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure/ Kidney Disease, Contrast-medium Induced Acute Kidney Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Red Wine
Arm Type
Active Comparator
Arm Description
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
Arm Title
White wine
Arm Type
Active Comparator
Arm Title
Beer
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Red wine
Other Intervention Name(s)
Frühburgunder 2006, Spätlese Trocken, Schloss Westerhaus, Rheinhessen, 12.5% vol
Intervention Description
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
Intervention Name(s)
White wine
Other Intervention Name(s)
Riesling feinherb 2009, Dr. Willkomm, Bernkastel-Kues, 12.5% vol
Intervention Description
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
Intervention Name(s)
Beer
Other Intervention Name(s)
Cologne mild beer (Kölsch), Gaffel Kölsch, Gaffel Brauerei Cologne, 4.8% vol
Intervention Description
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
Primary Outcome Measure Information:
Title
CI-AKI incidence
Description
Increment of serum-creatinin of 0.5 mg/dl or of at least 25% in 48 hours after contrast medium intake from baseline.
Time Frame
<48 hours after contrast-medium exposure
Secondary Outcome Measure Information:
Title
Biomarkers assessing acute kidney injury
Description
Changes of urinary neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram.
Time Frame
<48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Herzzentrum der Universität zu Köln
City
Cologne
ZIP/Postal Code
50937
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.cardiovascular-research.org
Description
study group homepage
Learn more about this trial
Effect of Red Wine, White Wine and Beer on Contrast-Medium Induced Acute Kidney Injury
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