Comparison of Blood and Crystalloid Cardioplegia

Completed

• Conditions: Aortic Stenosis; Myocardial Protection

• Registration Number: NCT01941420
• Lead Sponsor: Oslo University Hospital

Brief Summary

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. This group of patients was chosen for two reasons. First, these patients have left ventricular hypertrophy making the myocardium vulnerable to ischemia, secondly the investigators wanted to avoid the possible confounding effect of ischemia found in patients with variable degrees of coronary artery disease. Therefore, patients with additional significant coronary artery disease (≥ 50% stenoses) were excluded from the study.

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.

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2009-02
• Study First Submitted: 2012-05-07
• Study Completion: 2012-09
• 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: 70

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

Secondary Outcome Measures

Name	Time	Method
cytokines under ischemia.	70 min

Trial Locations

Locations (1)

Thoraxkirurgisk avdeling UUS; 🇳🇴 Oslo, Norway