Comparison of Blood Cardioplegia and Custodiol

NCT ID: NCT01941459

Last Updated: 2013-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-01-31

Brief Summary

Thru the last 20 years it has been a discussion witch solution that gives the best myocardial protection during cardiac arrest by heart operations.

• It has been a tendency that a blood based cardioplegia gives a better protection bye long ischemic times but it has not been possible too conclude in this matter.
• The investigators have two groups of cardioplegia, the blood based and, the crystalloid based cardioplegia.
• It has been done a lot of studies to see what kind of cardioplegia that gives the best myocardial protection. Different temperature, different amount and content, retrograde or antegrade or both, contentiously and further on have been tested without a clear conclusion.
• The investigators decided to make a study with a cohort of patients as homogenous as possible with a cross clamp time around 70 min.
• Adult patients' with a severe aortic stenoses without any other significant heart disease was included in our prospective randomised study.
• Patients with additional significant coronary artery disease (≥ 50% stenoses) were excluded from the study.
• The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the myocardial damage.

Detailed Description

Objective: Myocardial protection during a cardiac arrest is mostly managed with cardioplegia. To day we normally used a blood or crystalloid based solutions. It has been published a lot of papers comparing the too groups with different results. To our knowledge no prospective, randomized study has compared modified St Thomas based Blood and Crystalloid cardioplegia on the acknowledged markers (CK-MB, troponin-T) of myocardial damage during aortic valve replacement on patients without additional significant coronary artery disease.

Methods: 100 patients with aorta stenoses undergoing aortic valve replacement without significant coronary artery stenoses or other significant concomitant heart valve disease were included in the study. They were given antegrade cold blood or cold crystalloid cardioplegia delivered through the coronary Ostia every 20 min throughout the period of aortic cross-clamp. CK-MB and troponin-T were compared between the two groups.

Published 2010 in the journal of thoracic and cardiovascular surgery.

Conditions

Mitral Insufficiencies; Myocardial Protection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1 Custodiol

Custodiol

No interventions assigned to this group

2 Blood cardioplegia

Blood cardioplegia

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Inclution Criteria

• patients with mitral regurgitation equal to or larger than grade 3 out of 4.
• Ablation for atrial fibrillation was the only concomitant procedure that was allowed in addition to mitral valve surgery and these patients were block-randomized to ensure equally many patients with ablation in the two groups of cardioplegia.

Exclusion Criteria

• Patients with any other concomitant heart valve disease or coronary artery stenoses (≥ 50%) were excluded from the study.
• Age below 18
• Pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ullevaal University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bjørn Braathen

MD. Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theis Tønnessen, prof.dr.med

Role: STUDY_DIRECTOR

Thoraxkirurgisk avd. UUS

Bjørn Braathen, med.doc

Role: STUDY_CHAIR

Thoraxkir.avd. UUS

Locations

thoraxkirurgisk avd, UUS

Oslo, , Norway

Countries

Norway

Other Identifiers

2007-001780-30

Identifier Type: -

Identifier Source: org_study_id