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

University of Cologne

Status and phase: Completed; Phase 3

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

Treatments: Dietary Supplement: Beer; Dietary Supplement: White wine; Dietary Supplement: Red wine

Study type: Interventional

Funder types: Other

Identifiers

NCT01562925

RenPro-WINE

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 4 patient groups

Red Wine

Active Comparator group

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

Treatment:

Dietary Supplement: Red wine

White wine

Active Comparator group

Treatment:

Dietary Supplement: White wine

Beer

Active Comparator group

Treatment:

Dietary Supplement: Beer

Control

No Intervention group

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)