Heart disease requiring cardiovascular surgery with cardioplegic arrest
Conditions
Interventions
Standard cardiopulmonary bypass (CPB) setup is performed, and after aortic cross-clamping, modified del Nido cardioplegia solution is mixed with arterial blood from the CPB circuit at a ratio of 4:1 a
Sponsors
Nabeshima Junya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients meeting any of the following criteria Patients under 18 years of age at the time of consent, scheduled for cardiac surgery with cardioplegic arrest. Cohort A-1: Patients scheduled for closure of ventricular septal defect or atrial septal defect (without concomitant right ventricular outflow tract myectomy) and without genetic disorders. Cohort A-2: Patients other than those in Cohort A-1. Patients 18 years of age or older at the time of consent, scheduled for minimally invasive cardiac surgery (MICS*) with cardioplegic arrest. *In this study, MICS is defined as cardiac surgery without median sternotomy, including minimally invasive cardiac surgery and robot-assisted cardiac surgery. Cohort B-1: Patients scheduled for mitral valve repair/replacement or tricuspid valve repair/replacement without concomitant coronary artery bypass grafting or Maze procedure. Cohort B-2: Patients scheduled for aortic valve replacement without concomitant mitral valve surgery, tricuspid valve surgery, coronary artery bypass grafting, or Maze procedure. Cohort B-3: Patients not included in Cohort B-1 or Cohort B-2. 2) Patients who provide written informed consent to participate in this study, or whose legally authorized representative provides consent if the patient is under 18 years of age.
Exclusion criteria
Exclusion criteria: 1) Patients with allergies to any component of the modified del Nido cardioplegia solution. 2) Patients deemed unsuitable for participation in this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum postoperative Troponin I level | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Maximum postoperative CK-MB level 2) Number of administrations of cardioplegic solution 3) Total dose of cardioplegic solution 4) Aortic cross-clamp time | — |
Contacts
Public ContactJunya Nabeshima
Institute of Science Tokyo Hospital
Outcome results
None listed