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

This study has been completed.
Information provided by:
University of Oslo School of Pharmacy Identifier:
First received: October 25, 2005
Last updated: December 20, 2006
Last verified: December 2006
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.

Condition Intervention Phase
Kidney Failure, Chronic Coronary Artery Disease Drug: Nifedipine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.

Resource links provided by NLM:

Further study details as provided by University of Oslo School of Pharmacy:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 20
Study Start Date: June 2001
Estimated Study Completion Date: October 2005

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00244530

Rikshospitalet University Hospital
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Study Chair: Jan F Bugge, MD, PhD Rikshospitalet University Hospital, Oslo, Norway
  More Information Identifier: NCT00244530     History of Changes
Other Study ID Numbers: NIF-123
Study First Received: October 25, 2005
Last Updated: December 20, 2006

Keywords provided by University of Oslo School of Pharmacy:
Preventive Therapy
Calcium Channel Blockers
Kidney Failure, Chronic
Coronary Artery Bypass
Heart Valve Prosthesis Implantation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Renal Insufficiency
Kidney Failure, Chronic
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on September 25, 2017