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

Study Overview
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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.

Official Title
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Randomized Controlled Study for Evaluation of the Impact of Red Wine, White Wine and Beer Intake on Contrast-Medium Induced Acute Kidney Injury

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

Intervention / Treatment
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* Dietary Supplement: Red wine
* Dietary Supplement: White wine
* Dietary Supplement: Beer


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Red Wine<br>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<br>* 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<br>* Other names: Frühburgunder 2006, Spätlese Trocken, Schloss Westerhaus, Rheinhessen, 12.5% vol;|
| Active Comparator: White wine<br> | Dietary Supplement: White wine<br>* 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<br>* Other names: Riesling feinherb 2009, Dr. Willkomm, Bernkastel-Kues, 12.5% vol;|
| Active Comparator: Beer<br> | Dietary Supplement: Beer<br>* 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<br>* Other names: Gaffel Kölsch, Gaffel Brauerei Cologne, 4.8% vol;|
| No Intervention: Control<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | <48 hours after contrast-medium exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers assessing acute kidney injury | Changes of urinary neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram. | <48 hours |