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

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

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 Overview

• Status: Completed
• Conditions: Chronic Renal Failure/ Kidney Disease; Contrast-medium Induced Acute Kidney Injury
• Intervention / Treatment: Dietary supplement: Red wine; Dietary supplement: White wine; Dietary supplement: Beer

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50937
    • Herzzentrum der Universität zu Köln

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	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; Other Names: Frühburgunder 2006, Spätlese Trocken, Schloss Westerhaus, Rheinhessen, 12.5% vol
ACTIVE_COMPARATOR: White wine	Dietary supplement: 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; Other Names: Riesling feinherb 2009, Dr. Willkomm, Bernkastel-Kues, 12.5% vol
ACTIVE_COMPARATOR: Beer	Dietary supplement: 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; Other Names: Cologne mild beer (Kölsch); Gaffel Kölsch, Gaffel Brauerei Cologne, 4.8% vol
NO_INTERVENTION: Control; 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?

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

Collaborators and Investigators

• Sponsor: University of Cologne

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (ESTIMATE): March 26, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2013
• Last Update Submitted That Met QC Criteria: July 4, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Wounds and Injuries; Kidney Failure, Chronic; Acute Kidney Injury
• Other Study ID Numbers: RenPro-WINE