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Ischemic Postconditioning in Cardiac Surgery (IPICS)

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.
ClinicalTrials.gov Identifier: NCT01813968
Recruitment Status : Unknown
Verified October 2015 by Mari-Liis Kaljusto, Oslo University Hospital.
Recruitment status was:  Recruiting
First Posted : March 19, 2013
Last Update Posted : October 15, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cardiac Surgery Procedure: Ischemic postconditioning

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ischemic Postconditioning in Cardiac Surgery
Study Start Date : January 2013
Estimated Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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

Eligibility Criteria

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

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

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

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 Posted: March 19, 2013    Key Record Dates
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
Cardiac index