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Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00244530
First Posted: October 26, 2005
Last Update Posted: December 22, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Oslo School of Pharmacy
October 25, 2005
October 26, 2005
December 22, 2006
June 2001
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00244530 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery
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.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Kidney Failure, Chronic
  • Coronary Artery Disease
Drug: Nifedipine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00244530
NIF-123
Not Provided
Not Provided
Not Provided
Not Provided
University of Oslo School of Pharmacy
Not Provided
Study Chair: Jan F Bugge, MD, PhD Rikshospitalet University Hospital, Oslo, Norway
University of Oslo School of Pharmacy
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP