Protective Effect of RIPC Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII) (PANDA)

Nanjing Medical University

Status: Not yet enrolling

Conditions: Cardiopulmonary Bypass; Inflammatory Response During Cardiac Surgery; Cardiovascular Diseases

Treatments: Device: sham condition (control group); Device: Remote ischemic preconditioning (RIPC)

Study type: Interventional

Funder types: Other

Identifiers

NCT06707350

PANDA VII

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

500 participants in 2 patient groups

RIPC Group

Experimental group

Description:

6 cycles of 5-minute inflation and 5-minute deflation on 2 upper and lower libms with a blood pressure cuff at 72, 36, 24 hours before surgery

Treatment:

Device: Remote ischemic preconditioning (RIPC)

Control group

Sham Comparator group

Description:

8 cycles of 5-minute inflation to a pressure of 20 mm Hg followed by 5-minute cuff deflation on 2 upper and lower libms with a blood pressure cuff at 72, 36, 24 hours before surgery

Treatment:

Device: sham condition (control group)