Ischemic Postconditioning in Cardiac Surgery

Cardiac Surgery Clinical Trial

— IPICS  

Official title:

Ischemic Postconditioning in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813968
• Other study ID #: 2011/2613
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: June 5, 2018

Study information

• Verified date: December 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: June 5, 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Ischemia

Intervention

Procedure:
• Ischemic postconditioning

Locations

Country	Name	City	State
Norway	Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiac index between the groups during the first postoperative day	Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively	The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively