Blood cardioplegia versus cold crystalloid cardioplegia: A prospective randomized study

JRCT ID: jRCTs051220064

Registered date:22/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases which require aortic arch replacement
• Date of first enrollment: 22/07/2022
• Target sample size: 52
• Study type: Interventional
• Intervention(s): We administer blood cardioplegia or crystalloid cardioplegia during cardiac arrest in aortic arch replacement.

Outcome(s)

• Primary Outcome: Left ventricular ejection fraction in thoracic cardioechography 7 days postoperatively

Secondary Outcome

In-hospital death
Overall survival
Incidence of low output syndrome
Incidence of postoperative myocardial infarction
Dosage of cardioplegia
CK / CK-MB release
Incidence of left ventricular diastolic dysfunction
Incidence of right ventricular systolic dysfunction
Incidence of ventricular arrhythmia after return to spontaneous rhythm
Incidence of new-onset atrial fibrillation 48 hours postoperatively
Requirement for implantation of permanent pacemaker
Incidence of cerebral stroke
Incidence of renal dysfunction
Duration of ventilatory support
Amount of intraoperative bleeding
Amount of intraoperative and postoperative transfusion
Re-exploration for bleeding
Occurence of diseases, etc.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who receive aortic arch replacement
2. More than 20 years old
3. Patients who give written informed consent

Exclude criteria

1. Coronary artery stenosis (> 75%) which requires an intervention
2. Preoperative left ventricular systolic dysfunction (EF < 50%)
3. Emergent cases
4. Patients deemed inappropriate by the investigators

Related Information

• Primary Sponsor: Okada Kenji