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

Phase 3

Completed

• Conditions: Chronic Renal Failure/ Kidney Disease; Contrast-medium Induced Acute Kidney Injury
• Interventions: Dietary Supplement: White wine; Dietary Supplement: Red wine; Dietary Supplement: Beer

• Registration Number: NCT01562925
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-26
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-04
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
White wine	White wine	-
Red Wine	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
Beer	Beer	-

Primary Outcome Measures

Name	Time	Method
CI-AKI incidence	<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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Herzzentrum der Universität zu Köln; 🇩🇪 Cologne, Germany