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

Information source: University of Oslo School of Pharmacy
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Failure, Chronic; Coronary Artery Disease

Intervention: Nifedipine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Oslo School of Pharmacy

Official(s) and/or principal investigator(s):
Jan F Bugge, MD, PhD, Study Chair, Affiliation: Rikshospitalet University Hospital, Oslo, Norway

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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: 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: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Rikshospitalet University Hospital, Oslo 0027, Norway
Additional Information

Starting date: June 2001
Last updated: December 20, 2006

Page last updated: August 23, 2015

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