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

Coronary Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244530
• Other study ID #: NIF-123
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2005
• Last updated: December 20, 2006
• Start date: June 2001
• Est. completion date: October 2005

Study information

• Verified date: December 2006
• Source: University of Oslo School of Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Kidney Failure, Chronic
• Myocardial Ischemia
• Renal Insufficiency

Intervention

Drug:
• Nifedipine

Locations

Country	Name	City	State
Norway	Rikshospitalet University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo School of Pharmacy

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.