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Ischemic Postconditioning in Cardiac Surgery

NCT ID: NCT01813968

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-06-05

Brief Summary

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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

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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.

Conditions

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Cardiac Surgery

Keywords

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Ischemic postconditioning Adult cardiac surgery Aortic valve surgery Swan-Ganz Cardiac index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ischemic postconditioning

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

Group Type EXPERIMENTAL

Ischemic postconditioning

Intervention Type PROCEDURE

Control

Standard operating technique

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ischemic postconditioning

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mari-Liis Kaljusto

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2011/2613

Identifier Type: -

Identifier Source: org_study_id