Chronic Renal Failure/ Kidney Disease, Contrast-medium Induced Acute Kidney Injury
Conditions
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
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
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| CI-AKI incidence | <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
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers assessing acute kidney injury | <48 hours | Changes of urinary neutrophil gelatinase-associated lipocalin (NGAL), serum creatinin and cystatine after coronary angiogram. |
Countries
Germany