Effect of Red Wine, White Wine and Beer on Contrast-Medium Induced Acute Kidney Injury (RenPro-II-WINE)
This study is currently recruiting participants.
Verified April 2012 by University of Cologne
Sponsor:
University of Cologne
Information provided by (Responsible Party):
Dr. Fikret Er, University of Cologne
ClinicalTrials.gov Identifier:
NCT01562925
First received: March 22, 2012
Last updated: April 30, 2012
Last verified: April 2012
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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.
| Estimated Enrollment: | 260 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | July 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:
|
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562925
Contacts
| Contact: Fikret Er, MD | +4922147832544 | fikret.er@uk-koeln.de |
| Contact: Natig Gassanov, MD | +4922147832354 | natig.gassanov@uk-koeln.de |
Locations
| Germany | |
| Herzzentrum der Universität zu Köln | Recruiting |
| Cologne, Germany, 50937 | |
| Contact: Fikret Er, MD +4922147832544 fikret.er@uk-koeln.de | |
| Principal Investigator: Fikret Er, MD | |
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: | April 30, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Kidney Diseases Acute Kidney Injury Kidney Failure, Chronic |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
ClinicalTrials.gov processed this record on May 16, 2013