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

Phase 4

Completed

• Conditions: Kidney Failure, Chronic; Coronary Artery Disease

• Registration Number: NCT00244530
• Lead Sponsor: University of Oslo School of Pharmacy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Study Completion: 2005-10
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-25
• Study First Posted: 2005-10-26
• Status Verified: 2006-12
• Last Update Submitted: 2006-12-20
• Last Update Posted: 2006-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Rikshospitalet University Hospital; 🇳🇴 Oslo, Norway