Ischemic Postconditioning in Cardiac Surgery

Not Applicable

Completed

• Conditions: Cardiac Surgery
• Interventions: Procedure: Ischemic postconditioning

• Registration Number: NCT01813968
• Lead Sponsor: Oslo University Hospital

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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-14
• Study First Posted: 2013-03-19
• Primary Completion: 2018-06
• Study Completion: 2018-06-05
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ischemic postconditioning	Ischemic postconditioning	Ischemic postconditioning via the cardioplegia line starting with 2 min of reperfusion followed by 2 min of "ischemia" x 3

Primary Outcome Measures

Name	Time	Method
Change in cardiac index between the groups during the first postoperative day	The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively	Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively

Trial Locations

Locations (1)

Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål; 🇳🇴 Oslo, Norway