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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00244530

Enrollment

Registered

2005-10-26

Start date

2001-06-30

Completion date

2005-10-31

Last updated

2006-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Kidney Failure, Chronic

Keywords

Preventive Therapy, Calcium Channel Blockers, Kidney Failure, Chronic, Coronary Artery Bypass, Heart Valve Prosthesis Implantation

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.

Interventions

DRUGNifedipine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026