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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
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)
- 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.
- Biomarkers assessing acute kidney injury [ Time Frame: <48 hours ]Changes of urinary neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram.
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
|Herzzentrum der Universität zu Köln|
|Cologne, Germany, 50937|