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

• ClinicalTrials.gov Identifier: NCT01562925
• Recruitment Status: Completed
• First Posted: March 26, 2012
• Last Update Posted: July 8, 2013
• Sponsor: University of Cologne
• Information provided by (Responsible Party): Dr. Fikret Er, University of Cologne

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Renal Failure/ Kidney Disease; Contrast-medium Induced Acute Kidney Injury	Dietary Supplement: Red wine; Dietary Supplement: White wine; Dietary Supplement: Beer	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Study Start Date: March 2012
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: September 2012

Arms and Interventions

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 Name: 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 Name: 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)

Outcome Measures

Primary Outcome Measures :

1. CI-AKI incidence [ Time Frame: <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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Germany

Herzzentrum der Universität zu Köln

Cologne, Germany, 50937

Sponsors and Collaborators

University of Cologne

More Information

• Responsible Party: Dr. Fikret Er, MD, Assistant Professor, University of Cologne
• ClinicalTrials.gov Identifier: NCT01562925
• Other Study ID Numbers: RenPro-WINE
• First Posted: March 26, 2012
• Last Update Posted: July 8, 2013
• Last Verified: July 2013

Additional relevant MeSH terms:

Kidney Diseases; Acute Kidney Injury; Kidney Failure, Chronic; Wounds and Injuries; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic