ClinicalTrials.Veeva

Menu

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

U

University of Oslo School of Pharmacy

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease
Kidney Failure, Chronic

Treatments

Drug: Nifedipine

Study type

Interventional

Funder types

Other

Identifiers

NCT00244530
NIF-123

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems