Protective Effect of Remote Ischemic Preconditioning (RIPC) Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiopulmonary Bypass
- Sponsor
- Nanjing Medical University
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- ∆SOFA
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
Remote ischaemic pre-conditioning (RIPC) has been recognized as a low-cost, non-invasive intervention method by applying brief ischaemia and reperfusion on an arm or a leg. Previous studies have mainly focused on the organoprotective effects of RIPC in patients undergoing cardiac surgery. However, whether it has an organ-protecting effect is still highly debated. We aimed to determine whether intensive RIPC can prevent from negative inflammatory response and organ dysfunction as well as postoperative complications in patients undergoing cardiovascular surgery.
Investigators
Hong Liu
Principal Investigator of China 5A Network
Nanjing Medical University
Eligibility Criteria
Inclusion Criteria
- •patients at high risk for organ dysfunctions who underwent elective cardiovascular surgery requiring cardiopulmonary bypass (CPB);
- •age of 18 -80 years old, regardless of gender;
- •subjects voluntarily participate in the trialand sign the informed consent;
Exclusion Criteria
- •Arm fracture, skin injury or infection;
- •There is limb nerve injury;
- •Limb placement PICC, arteriovenous fistula and other devices that affect armband placement;
- •There are basic vascular lesions and poor blood supply at the extremities;
- •Limb thrombosis.
Outcomes
Primary Outcomes
∆SOFA
Time Frame: within the prior 7 days after cardiac surgery.
the change in sequential organ failure assessment score \[∆SOFA\]) was defined as the difference between the mean total postoperative SOFA score, calculated maximally to the 9th postoperative day, and the basal SOFA score.
Secondary Outcomes
- Plasma interleukin-1 levels(within the prior 7 days after cardiac surgery.)