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

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Red wine
White wine
Beer
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Renal Failure/ Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herzzentrum der Universität zu Köln

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Red Wine

White wine

Beer

Control

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Biomarkers assessing acute kidney injury
Changes of urinary neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram.

Full Information

First Posted
March 22, 2012
Last Updated
July 4, 2013
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT01562925
Brief Title
Effect of Red Wine, White Wine and Beer on Contrast-Medium Induced Acute Kidney Injury
Acronym
RenPro-II-WINE
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 Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure/ Kidney Disease, Contrast-medium Induced Acute Kidney Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Red Wine
Arm Type
Active Comparator
Arm Description
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
Arm Title
White wine
Arm Type
Active Comparator
Arm Title
Beer
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Red wine
Other Intervention Name(s)
Frühburgunder 2006, Spätlese Trocken, Schloss Westerhaus, Rheinhessen, 12.5% vol
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
White wine
Other Intervention Name(s)
Riesling feinherb 2009, Dr. Willkomm, Bernkastel-Kues, 12.5% vol
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Beer
Other Intervention Name(s)
Cologne mild beer (Kölsch), Gaffel Kölsch, Gaffel Brauerei Cologne, 4.8% vol
Intervention Description
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
Primary Outcome Measure Information:
Title
CI-AKI incidence
Description
Increment of serum-creatinin of 0.5 mg/dl or of at least 25% in 48 hours after contrast medium intake from baseline.
Time Frame
<48 hours after contrast-medium exposure
Secondary Outcome Measure Information:
Title
Biomarkers assessing acute kidney injury
Description
Changes of urinary neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram.
Time Frame
<48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Herzzentrum der Universität zu Köln
City
Cologne
ZIP/Postal Code
50937
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.cardiovascular-research.org
Description
study group homepage

Learn more about this trial

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

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