Comparison of Blood Cardioplegia and Custodiol

Completed

• Conditions: Mitral Insufficiencies; Myocardial Protection

• Registration Number: NCT01941459
• Lead Sponsor: Ullevaal University Hospital

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.

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Study First Submitted: 2012-05-07
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-12
• Last Update Submitted: 2013-09-12
• Study First Posted: 2013-09-13
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CK-MB ,troponin-T	72 hours

Trial Locations

Locations (1)

thoraxkirurgisk avd, UUS; 🇳🇴 Oslo, Norway