Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery
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To compare renal function (51Cr-EDTA clearance) 48 hours post open-heart surgery (coronary bypass or valve surgery) in patients with impaired renal function after randomization to either nifedipine infusion at start of surgery and the following 24 hours or placebo (0.9% saline infusion). Study hypothesis is that nifedipine has a prophylactic effect on decline in renal function.
Postoperative Renal Function After Open-Heart Surgery in Patients With Impaired Renal Function Preoperatively. A Study of the Calcium Channel Blocker Nifedipine's Prophylactic Effect on Further Decline in Renal Function.
Study Start Date
Estimated Study Completion Date
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Primary efficacy endpoint is change in renal function, evaluated by 51Cr-EDTA clearance between 24 hours pre open-heart surgery and 48 hours post open-heart surgery. Sample size is 20, ten in each group.
Secondary Outcome Measures
Change in renal function after open-heart surgery, as measured by cimetidine refined serum creatinine clearance with measurements preoperatively and 2–6 hours, 20–24 hours and 44–48 hours postoperatively. Need for dialysis post-operatively.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients of either gender above 18 years of age.
Patients with significant coronary stenosi(e)s (≥ 75% coronary artery lumen surface stenosi(e)s and / or aortic- or mitral valve vitriuim that are accepted for coronary artery bypass surgery and/or valve replacement surgery.
Patients with impaired renal function, defined as increased serum- creatinine. Men: ≥ 150 µmol/l and Women: ≥130 µmol/l.