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Ischemic Postconditioning in Cardiac Surgery (IPICS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Oslo University Hospital
Sponsor:
Collaborators:
Medical University of Warsaw
University Hospital of North Norway
Tartu University Hospital, Estonia
Oulu University Hospital
Almazov Federal Center of Heart, Blood and Endocrinology
Information provided by (Responsible Party):
Mari-Liis Kaljusto, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01813968
First received: March 13, 2013
Last updated: March 14, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ischemic Postconditioning in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively


Estimated Enrollment: 250
Study Start Date: January 2013
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813968

Contacts
Contact: Mari-Liis Kaljusto, MD, PhD 22118080 ext +47 m.l.kaljusto@medisin.uio.no
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, Estonia
Oulu University Hospital
Almazov Federal Center of Heart, Blood and Endocrinology
  More Information

No publications provided

Responsible Party: Mari-Liis Kaljusto, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01813968     History of Changes
Other Study ID Numbers: 2011/2613
Study First Received: March 13, 2013
Last Updated: March 14, 2013
Health Authority: Norway: Ethics Committee

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

ClinicalTrials.gov processed this record on November 27, 2014