Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery
Information source: University of Oslo School of Pharmacy
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Failure, Chronic; Coronary Artery Disease
Intervention: Nifedipine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Oslo School of Pharmacy Official(s) and/or principal investigator(s):
Jan F Bugge, MD, PhD, Study Chair, Affiliation: Rikshospitalet University Hospital, Oslo, Norway
Summary
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.
Clinical Details
Official title: 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 design: Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients of either gender above 18 years of age.
2. 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.
3. Patients with impaired renal function, defined as increased serum- creatinine. Men: ≥
150 µmol/l and Women: ≥130 µmol/l.
Exclusion Criteria:
1. Patients on maintenance hemodialysis
2. Renal transplant patients
3. Patients with ejection fraction ≤ 35%
4. Patients with unstable angina pectoris
Locations and Contacts
Rikshospitalet University Hospital, Oslo 0027, Norway
Additional Information
Starting date: June 2001
Ending date: October 2005
Last updated: December 20, 2006
|
