Ischemic Postconditioning in Cardiac Surgery (IPICS)

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