Ischemic Preconditioning
Conditions
Keywords
heart transplantation, ischemia-reperfusion injury
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREcross-preconditioning
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.
Sponsors
Mengya Liang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients who underwent heart transplantation； 2. Signed informed consent.
Exclusion criteria
1. Systemic active infection; 2. Refractory respiratory failure or renal failure; 3. Severe systemic diseases with limited survival time. 4. ABO blood groups incompatibility 5. positive serum HIV antibody; 6. drug or alcohol abusing; 7. Mentally ill; 8. Recent history of severe pulmonary embolism 9. Have not signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum troponin T/ creatine kinase-MB level | 3days | troponin T/ creatine kinase-MB at definitive time points ( baseline, crossclamping, reperfusion, 6,24,48 and 72 hours postoperatively) |
| Number of Participants with major adverse cardiacand cerebrovascular events (MACCE) in one year postoperatively | 1year | MACCE include death from cardiovascular causes, nonfatal myocardial infarction, coronary revascularization, or strok |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inotrope score | 3days | calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery |
| serum creatinine level | 3days | 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 |
| ICU time | up to 2 weeks | duration of stay in the intensive care unit and hospital |
| 6-minute walk test | 2weeks | distance on the 6-minute walk test two weeks after surgery |
Countries
China
Contacts
Primary ContactMengya Liang
Backup ContactHuayang Li
Outcome results
None listed