Cardiopulmonary Bypass, Cardiovascular Diseases, Inflammatory Response During Cardiac Surgery
Conditions
Keywords
inflammation
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.
Interventions
DEVICERemote ischemic preconditioning (RIPC)
8 cycles of 5-minute inflation and 5-minute deflation on 2 upper and lower limbs with a blood pressure cuff
DEVICEsham condition (control group)
8 cycles of 5-minute inflation to a pressure of 20 mm Hg followed by 5-minute cuff deflation.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
* 1\) Arm fracture, skin injury or infection; * 2\) There is limb nerve injury; * 3\) Limb placement PICC, arteriovenous fistula and other devices that affect armband placement; * 4\) There are basic vascular lesions and poor blood supply at the extremities; * 5\) Limb thrombosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ∆SOFA | 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
| Measure | Time frame | Description |
|---|---|---|
| Plasma interleukin-1 levels | within the prior 7 days after cardiac surgery. | Plasma interleukin-1 levels within the prior 7 days after cardiac surgery. |
Countries
China
Contacts
Primary ContactHong Liu, MD
Backup ContactYong-feng Shao, MD
Outcome results
None listed