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NCT Number: NCT01562925

Effect of Red Wine, White Wine and Beer 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Herzzentrum der Universität zu Köln

Cologne, 50937, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Frühburgunder 2006, Spätlese Trocken, Schloss Westerhaus, Rheinhessen, 12.5% vol

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

Other names: Riesling feinherb 2009, Dr. Willkomm, Bernkastel-Kues, 12.5% vol

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

Other names: Cologne mild beer (Kölsch), Gaffel Kölsch, Gaffel Brauerei Cologne, 4.8% vol

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

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

Acronym: RenPro-II-WINE

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 26, 2012
Registry last updated
Jul 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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