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

This study has been completed.

First Received: October 25, 2005 Last Updated: December 20, 2006 History of Changes

Sponsored by:	University of Oslo School of Pharmacy
Information provided by:	University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:	NCT00244530

Purpose

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 IV

MedlinePlus related topics: Calcium Coronary Artery Bypass Surgery Coronary Artery Disease Heart Surgery Kidney Failure Surgery

Drug Information available for: Nifedipine Calcium gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244530

Locations

Norway
Rikshospitalet University Hospital
Oslo, Norway, 0027

Sponsors and Collaborators

University of Oslo School of Pharmacy

Investigators

Study Chair:

Jan F Bugge, MD, PhD

Rikshospitalet University Hospital, Oslo, Norway

More Information

No publications provided

Study ID Numbers:	NIF-123
Study First Received:	October 25, 2005
Last Updated:	December 20, 2006
ClinicalTrials.gov Identifier:	NCT00244530 History of Changes
Health Authority:	Norway: Directorate for Health and Social Affairs

Keywords provided by University of Oslo School of Pharmacy:

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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Vasodilator Agents
Renal Insufficiency
Heart Diseases
Myocardial Ischemia
Kidney Failure, Chronic
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Ischemia

Arteriosclerosis
Nifedipine
Coronary Disease
Calcium, Dietary
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Coronary Artery Disease
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Kidney Failure, Chronic
Calcium Channel Blockers
Arteriosclerosis
Reproductive Control Agents
Nifedipine
Membrane Transport Modulators
Urologic Diseases
Tocolytic Agents

Therapeutic Uses
Cardiovascular Diseases
Kidney Diseases
Arterial Occlusive Diseases
Heart Diseases
Vascular Diseases
Cardiovascular Agents
Pharmacologic Actions
Coronary Disease
Renal Insufficiency, Chronic
Coronary Artery Disease
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009