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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Fikret Er, University of Cologne
ClinicalTrials.gov Identifier:
NCT01562925
First received: March 22, 2012
Last updated: July 4, 2013
Last verified: July 2013
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • CI-AKI incidence [ Time Frame: <48 hours after contrast-medium exposure ] [ Designated as safety issue: Yes ]
    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:
  • Biomarkers assessing acute kidney injury [ Time Frame: <48 hours ] [ Designated as safety issue: Yes ]
    Changes of urinary neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram.


Enrollment: 260
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562925

Locations
Germany
Herzzentrum der Universität zu Köln
Cologne, Germany, 50937
Sponsors and Collaborators
University of Cologne
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Fikret Er, MD, Assistant Professor, University of Cologne
ClinicalTrials.gov Identifier: NCT01562925     History of Changes
Other Study ID Numbers: RenPro-WINE
Study First Received: March 22, 2012
Last Updated: July 4, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Acute Kidney Injury
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014