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

NCT01562925 | Completed Phase 3 DMC

• 1 other identifier: RenPro-WINE
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Biomarkers assessing acute kidney injury

  <48 hours

Study Arms (4)

Red Wine

ACTIVE COMPARATOR

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

White wine

ACTIVE COMPARATOR

Dietary Supplement: White wine

Beer

ACTIVE COMPARATOR

Dietary Supplement: Beer

Control

NO INTERVENTION

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)

Interventions

Red wine DIETARY_SUPPLEMENT

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

Also known as: Frühburgunder 2006, Spätlese Trocken, Schloss Westerhaus, Rheinhessen, 12.5% vol

Red Wine

White wine DIETARY_SUPPLEMENT

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

Also known as: Riesling feinherb 2009, Dr. Willkomm, Bernkastel-Kues, 12.5% vol

White wine

Beer DIETARY_SUPPLEMENT

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

Also known as: Cologne mild beer (Kölsch), Gaffel Kölsch, Gaffel Brauerei Cologne, 4.8% vol

Beer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Herzzentrum der Universität zu Köln

Cologne, 50937, Germany

Location

Related Links

• study group homepage

MeSH Terms

Interventions

Beer

Intervention Hierarchy (Ancestors)

Alcoholic Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Beverages; Fermented Foods; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 8, 2013

Record last verified: 2013-07

Locations

DE (1)