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

University of Cologne260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

260

Conditions

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

Red wineDIETARY_SUPPLEMENT

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

White wineDIETARY_SUPPLEMENT

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

BeerDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: <48 hours after contrast-medium exposure

Secondary Outcomes

Biomarkers assessing acute kidney injury

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

Time frame: <48 hours