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Ischemic Postconditioning in Cardiac Surgery (IPICS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Mari-Liis Kaljusto, Oslo University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01813968
First Posted: March 19, 2013
Last Update Posted: October 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medical University of Warsaw
University Hospital of North Norway
Tartu University Hospital
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Information provided by (Responsible Party):
Mari-Liis Kaljusto, Oslo University Hospital
  Purpose
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.

Condition Intervention
Cardiac Surgery Procedure: Ischemic postconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ischemic Postconditioning in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Mari-Liis Kaljusto, Oslo University Hospital:

Primary Outcome 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


Estimated Enrollment: 250
Study Start Date: January 2013
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ischemic postconditioning
Ischemic postconditioning via the cardioplegia line starting with 2 min of reperfusion followed by 2 min of "ischemia" x 3
Procedure: Ischemic postconditioning
No Intervention: Control
Standard operating technique

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813968


Contacts
Contact: Mari-Liis Kaljusto, MD, PhD 22118080 ext +47 m.l.kaljusto@gmail.com
Contact: Jarle Vaage, MD, PhD 22118080 ext +47 i.j.vaage@medisin.uio.no

Locations
Norway
Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål Recruiting
Oslo, Norway, 0424
Principal Investigator: Mari-Liis Kaljusto, MD, PhD         
Sponsors and Collaborators
Oslo University Hospital
Medical University of Warsaw
University Hospital of North Norway
Tartu University Hospital
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
  More Information

Responsible Party: Mari-Liis Kaljusto, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01813968     History of Changes
Other Study ID Numbers: 2011/2613
First Submitted: March 13, 2013
First Posted: March 19, 2013
Last Update Posted: October 15, 2015
Last Verified: October 2015

Keywords provided by Mari-Liis Kaljusto, Oslo University Hospital:
Ischemic postconditioning
Adult cardiac surgery
Aortic valve surgery
Swan-Ganz
Cardiac index