Ischemic Postconditioning in Cardiac Surgery

Overview

Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven both in animal models and in humans. This study aims to investigate the effect of ischemic postconditioning on postoperative hemodynamic function in a standard heart surgery patient population.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 2016

Detailed Description

Ischemic postconditioning is studied using cardiopulmonary bypass (CPB) and moderate hypothermia (32-34°C) in a patient population undergoing surgery of the aortic valve (repair/replacement ) or the ascending aorta. Postconditioning is applied by introducing reperfusion/ischemia via the cardioplegia line while the aorta is still cross-clamped thereby preventing the risk of additional neurological complications. All patients > 20 years eligible for aortic or aortic valve surgery and not affected by exclusion criteria, will be included.

The study is carried out as a randomised controlled multicenter study including 5-6 heart surgery centers.

Interventions

  • Procedure: Ischemic postconditioning

Arms, Groups and Cohorts

  • Experimental: Ischemic postconditioning
    • Ischemic postconditioning via the cardioplegia line starting with 2 min of reperfusion followed by 2 min of “ischemia” x 3
  • No Intervention: Control
    • Standard operating technique

Clinical Trial Outcome Measures

Primary Measures

  • Change in cardiac index between the groups during the first postoperative day
    • Time Frame: The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively
    • Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively

Participating in This Clinical Trial

Inclusion Criteria

Patients undergoing elective surgery of the ascending aorta or the aortic valve

Exclusion Criteria

  • Coronary artery disease requiring bypass surgery
  • Tricuspid valve surgery
  • Mitral valve surgery
  • Atrial fibrillation (permanent or paroxysmal with or without concomitant ablation procedure)
  • Patients on per oral or parenteral steroid therapy (inhalational steroids are allowed)
  • Patients with autoimmune diseases
  • "Redo" operations
  • Active endocarditis (ongoing antibiotic therapy)
  • On the discretion of the operating surgeon or anaesthesiologist

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oslo University Hospital
  • Collaborator
    • Medical University of Warsaw
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mari-Liis Kaljusto, MD, PhD – Oslo University Hospital
  • Overall Contact(s)
    • Mari-Liis Kaljusto, MD, PhD, 22118080, m.l.kaljusto@gmail.com

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