Effect of Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Comparison of PaO2/FiO2 over 24 hours after cardiac surgery
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing heart surgery on cardiopulmonary bypass
- •Patients aged 18 years to 80 years
Exclusion Criteria
- •Inability to give informed consent
- •Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) <60 mmHg or FEV1<50% predicted)
- •Prior receipt of chemotherapy or radiation therapy or immunotherapy
- •left ventricular ejection fraction less than 30%
- •preoperative use of inotropics or mechanical assist device
- •Patients with significant hepatic dysfunction (Prothrombin>2.0 ratio)
- •Patients with known renal failure with a GFR<30 mL/min/1.73 m2
- •recent myocardial infarction (within 7 days)
- •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℃)
- •Significant peripheral arterial disease affecting the upper limbs
- •surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,, off-pump surgery, emergency surgery
Outcomes
Primary Outcomes
Comparison of PaO2/FiO2 over 24 hours after cardiac surgery
Time Frame: 24 hours post surgery
Secondary Outcomes
- All-cause mortality(30 days post surgery)
- Postoperative Pulmonary Complications(30 days post surgery)
Investigators
Su Liu
Principal Investigator
Xuzhou Medical University