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

Chronic Renal Failure/ Kidney Disease Clinical Trial

— RenPro-II-WINE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562925
• Other study ID #: RenPro-WINE
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2012
• Last updated: July 4, 2013
• Start date: March 2012
• Est. completion date: September 2012

Study information

• Verified date: July 2013
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Germany	Herzzentrum der Universität zu Köln	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Biomarkers assessing acute kidney injury	Changes of urinary neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram.	<48 hours	Yes