In recent years, a large number of studies confirmed the protective effect of ischemic preconditioning on myocardium against ischemia/reperfusion injury, but the clinical data of the effectiveness of ischemic preconditioning in heart transplantation is still missing. Inspired by the promising data of ischemic preconditioning from the previous reports, the investigators firstly introduce a novel method of cross ischemic preconditioning technique to prevent ischemia/reperfusion injury to heart transplant recipients. This study will evaluate whether this cross-preconditioning technique would attenuate ischemia/ reperfusion injury to the heart transplant recipients, reduce Intensive Care Unit(ICU) and total hospitalization stays and the incidence of cardiovascular adverse events and improve the long-term survival outcomes.
Patients receiving heart transplantation are randomly assigned into the cross ischemic preconditioning (CICP) intervention group and the control group. (the Statistical Analysis System (SAS) software was used to generate a random number table and randomly divided into two groups). After the establishment of the cardiopulmonary bypass, the ascending aorta of the CICP group will be crossclamped 2 minutes, separated by a 3-minute rest interval, and repeated successively on 2 occasions. The recipients in the control group are to undergo routine cardiopulmonary bypass procedure of heart transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
After the establishment of the cardiopulmonary bypass, the ascending aorta of the CICP group will be crossclamped 2 minutes, separated by a 3-minute rest interval, and repeated successively on 2 occasions.
The first affiliated hospital of sun yat-sen university
Guangzhou, Guangdong, China
RECRUITINGserum troponin T/ creatine kinase-MB level
troponin T/ creatine kinase-MB at definitive time points ( baseline, crossclamping, reperfusion, 6,24,48 and 72 hours postoperatively)
Time frame: 3days
Number of Participants with major adverse cardiacand cerebrovascular events (MACCE) in one year postoperatively
MACCE include death from cardiovascular causes, nonfatal myocardial infarction, coronary revascularization, or strok
Time frame: 1year
inotrope score
calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery
Time frame: 3days
serum creatinine level
grade 1, 2, or 3 acute kidney injury within 72 hours after surgery (assessed on the basis of the increase in the serum creatinine level according to the International Kidney Disease: Improving Global Outcomes classification
Time frame: 3days
ICU time
duration of stay in the intensive care unit and hospital
Time frame: up to 2 weeks
6-minute walk test
distance on the 6-minute walk test two weeks after surgery
Time frame: 2weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.