Lung Injury, Remote Ischemic Preconditioning
Conditions
Brief summary
During cardiac surgery with cardiopulmonary bypass , pulmonary dysfunction remains to be a problem complicating the postoperative course of the patients.Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.Recent several trials suggested that RIPC could provide pulmonary protection by reducing serum biomarkers,however,whether the RIPC can improve the clinical outcomes in patients undergoing on-pump cardiac surgery,is still uncertain. The study hypothesis is: remote ischemic preconditioning will provide lung-protective effect and improve clinical outcomes in patients undergoing cardic surgery.
Detailed description
Remote ischemic preconditioning (RIPC) protocol will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood pressure cuff inflated to a pressure 200mmHg
Interventions
PROCEDURERemote Ischemic Preconditioning
RIPC will be induced during 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
DOUBLE (Subject, 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. Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) \<60 mmHg or FEV1\<50% predicted) 3. Prior receipt of chemotherapy or radiation therapy or immunotherapy 4. left ventricular ejection fraction less than 30% 5. preoperative use of inotropics or mechanical assist device 6. Patients with significant hepatic dysfunction (Prothrombin\>2.0 ratio) 7. Patients with known renal failure with a GFR\<30 mL/min/1.73 m2 8. recent myocardial infarction (within 7 days) 9. Systemic or local active infections (either clinically defined or suggested by evidence such as elevated C-reactive protein levels, leukocytosis, or a body temperature\>38℃) 10. Significant peripheral arterial disease affecting the upper limbs 11. surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,, off-pump surgery, emergency surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of PaO2/FiO2 over 24 hours after cardiac surgery | 24 hours post surgery |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality | 30 days post surgery |
| Postoperative Pulmonary Complications | 30 days post surgery |
Countries
China
Contacts
Primary ContactLiu Su, M.D/Ph.D
Outcome results
None listed