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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01562925
Acronym
RenPro-II-WINE
Enrollment
260
Registered
2012-03-26
Start date
2012-03-31
Completion date
2012-09-30
Last updated
2013-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIETARY_SUPPLEMENTRed 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

DIETARY_SUPPLEMENTWhite 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

DIETARY_SUPPLEMENTBeer

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

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CI-AKI incidence<48 hours after contrast-medium exposureIncrement of serum-creatinin of 0.5 mg/dl or of at least 25% in 48 hours after contrast medium intake from baseline.

Secondary

MeasureTime frameDescription
Biomarkers assessing acute kidney injury<48 hoursChanges of urinary neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026