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Completed

NCT Number: NCT01813968

Ischemic Postconditioning in Cardiac Surgery

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.

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Key information

Conditions

Cardiac Surgery

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ischemic postconditioning

Procedure

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
  • Medical University of Warsaw
  • University Hospital of North Norway

Registry information

Acronym: IPICS

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2013
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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