Ischemic Postconditioning in Cardiac Surgery (IPICS)

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University of Oslo (UIO)

Status

Completed

Conditions

Cardiac Surgery

Treatments

Procedure: Ischemic postconditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT01813968
2011/2613

Details and patient eligibility

About

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.

Full 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.

Enrollment

209 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

209 participants in 2 patient groups

Ischemic postconditioning
Experimental group
Description:
Ischemic postconditioning via the cardioplegia line starting with 2 min of reperfusion followed by 2 min of "ischemia" x 3
Treatment:
Procedure: Ischemic postconditioning
Control
No Intervention group
Description:
Standard operating technique

Trial contacts and locations

1

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Central trial contact

Jarle Vaage, MD, PhD; Mari-Liis Kaljusto, MD, PhD

Data sourced from clinicaltrials.gov

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