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Ischemic Postconditioning in Cardiac Surgery (IPICS)

Primary Purpose

Cardiac Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Ischemic postconditioning
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Surgery focused on measuring Ischemic postconditioning, Adult cardiac surgery, Aortic valve surgery, Swan-Ganz, Cardiac index

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Cardiothoracic Surgery, Oslo University Hospital, UllevålRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ischemic postconditioning

Control

Arm Description

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

Standard operating technique

Outcomes

Primary Outcome Measures

Change in cardiac index between the groups during the first postoperative day
Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively

Secondary Outcome Measures

Full Information

First Posted
March 13, 2013
Last Updated
October 13, 2015
Sponsor
Oslo University Hospital
Collaborators
Medical University of Warsaw, University Hospital of North Norway, Tartu University Hospital, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
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1. Study Identification

Unique Protocol Identification Number
NCT01813968
Brief Title
Ischemic Postconditioning in Cardiac Surgery
Acronym
IPICS
Official Title
Ischemic Postconditioning in Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Medical University of Warsaw, University Hospital of North Norway, Tartu University Hospital, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery
Keywords
Ischemic postconditioning, Adult cardiac surgery, Aortic valve surgery, Swan-Ganz, Cardiac index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ischemic postconditioning
Arm Type
Experimental
Arm Description
Ischemic postconditioning via the cardioplegia line starting with 2 min of reperfusion followed by 2 min of "ischemia" x 3
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard operating technique
Intervention Type
Procedure
Intervention Name(s)
Ischemic postconditioning
Primary Outcome Measure Information:
Title
Change in cardiac index between the groups during the first postoperative day
Description
Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively
Time Frame
The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mari-Liis Kaljusto, MD, PhD
Phone
22118080
Ext
+47
Email
m.l.kaljusto@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jarle Vaage, MD, PhD
Phone
22118080
Ext
+47
Email
i.j.vaage@medisin.uio.no
Facility Information:
Facility Name
Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mari-Liis Kaljusto, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Ischemic Postconditioning in Cardiac Surgery

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