Back to resultsProphylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery
Primary Purpose
Kidney Failure, Chronic, Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Nifedipine
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Failure, Chronic focused on measuring Preventive Therapy, Calcium Channel Blockers, Kidney Failure, Chronic, Coronary Artery Bypass, Heart Valve Prosthesis Implantation
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients on maintenance hemodialysis Renal transplant patients Patients with ejection fraction ≤ 35% Patients with unstable angina pectoris
Sites / Locations
- Rikshospitalet University Hospital
Outcomes
Primary Outcome Measures
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.
Full Information
NCT ID
NCT00244530
First Posted
October 25, 2005
Last Updated
December 20, 2006
Sponsor
University of Oslo School of Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT00244530
Brief Title
Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oslo School of Pharmacy
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, Coronary Artery Disease
Keywords
Preventive Therapy, Calcium Channel Blockers, Kidney Failure, Chronic, Coronary Artery Bypass, Heart Valve Prosthesis Implantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Patients on maintenance hemodialysis
Renal transplant patients
Patients with ejection fraction ≤ 35%
Patients with unstable angina pectoris
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan F Bugge, MD, PhD
Organizational Affiliation
Rikshospitalet University Hospital, Oslo, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Rikshospitalet University Hospital
City
Oslo
ZIP/Postal Code
0027
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery
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