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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2005-10-31

Brief Summary

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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

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Conditions

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Kidney Failure, Chronic Coronary Artery Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Nifedipine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jan F Bugge, MD, PhD

Role: STUDY_CHAIR

Rikshospitalet University Hospital, Oslo, Norway

Locations

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Rikshospitalet University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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NIF-123

Identifier Type: -

Identifier Source: org_study_id