Myocardial Injury, Remote Ischemic Preconditioning
Conditions
Brief summary
During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle and the lung.The heart and lung injury is a serious complication ,which increases both mortality and morbidity of cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.Recent some trials suggested that RIPC could provide myocardial protection by reducing serum cardiac biomarkers,however, more recent multicenter studies\[9-11\] had failed to show the protective effects of RIPC with respect to the troponin release and lung injury. Remote ischemic preconditioning (RIPC) is reported to have the early-phase and delayed-phase organ protective effects, whether the modified RIPC protocol induced repeatedly has the cardiopulmonary protective effect is still uncertain.
Detailed description
modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective effects of RIPC.The single RIPC protocol was induced by three cycles of upper-limb ischemia, a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to 200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.
Interventions
PROCEDUREModified Remote Ischemic Preconditioning
mRIPC will be induced at 24 h, 12 h and 1 h before surgery and once before induction of anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg
PROCEDUREControl
Control group witnout remote ischemic preconditioning
Sponsors
Xuzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing heart surgery on cardiopulmonary bypass 2. Patients aged 18 years to 80 years
Exclusion criteria
1. Inability to give informed consent 2. Cardiogenic shock 3. Cardiac arrest on current admission 4. Left ventricular ejection fraction less than 30% 5. Current atrial fibrillation 6. Preoperative use of inotropics or mechanical assist device 7. Patients with significant hepatic dysfunction (Prothrombin\>2.0 ratio) 8. Patients with known renal failure with a GFR\<30 mL/min/1.73 m2 9. Patients with significant pulmonary disease (FEV1\<40% predicted) 10. Recent myocardial infarction (within 7 days) 11. Recent systemic infection or sepsis (within 7 days) 12. Severe stroke (within 2 months) 13. Significant peripheral arterial disease affecting the upper limbs 14. Previous serious psychiatric disorders (e.g. schizophrenia, dementia) 15. Surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,off-pump surgery, emergency surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Troponin I serum release over 24 hours after surgery | 24 hours post surgery |
Secondary
| Measure | Time frame |
|---|---|
| PaO2/FiO2 ratio over 24 hours after surgery | 24 hours post surgery |
| salveolar-arterial oxygen gradient over 24 hours after surgery | 24 hours post surgery |
| Inotrope score | 12 hours post surgery |
Countries
China
Outcome results
None listed