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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06707350
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-24
• Last Update Submitted: 2024-11-24
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Study Start: 2024-12-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
∆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 Outcome Measures

Name	Time	Method
Plasma interleukin-1 levels	within the prior 7 days after cardiac surgery.	Plasma interleukin-1 levels within the prior 7 days after cardiac surgery.

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China