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

NCT00244530 | Completed Phase 4

• 1 other identifier: NIF-123
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure, Chronic; Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Nifedipine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients on maintenance hemodialysis
• Renal transplant patients
• Patients with ejection fraction ≤ 35%
• Patients with unstable angina pectoris

Sponsors & Collaborators

• University of Oslo School of Pharmacy: lead

Study Sites (1)

Rikshospitalet University Hospital

Oslo, 0027, Norway

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Coronary Artery Disease

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jan F Bugge, MD, PhD

  Rikshospitalet University Hospital, Oslo, Norway

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 26, 2005
• Study Start: June 1, 2001
• Study Completion: October 1, 2005
• Last Updated: December 22, 2006

Record last verified: 2006-12

Locations

NO (1)