Protective Effect of RIPC Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote ischemic preconditioning (RIPC), sham condition (control group).
- Who it may be relevant to
- Registry conditions: Cardiopulmonary Bypass, Cardiovascular Diseases, Inflammatory Response During Cardiac Surgery. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Protective Effect of Remote Ischemic Preconditioning (RIPC) Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII)
Overview
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
- Device Remote ischemic preconditioning (RIPC)
8 cycles of 5-minute inflation and 5-minute deflation on 2 upper and lower limbs with a blood pressure cuff - Device sham condition (control group)
8 cycles of 5-minute inflation to a pressure of 20 mm Hg followed by 5-minute cuff deflation.
Primary outcome measures
- ∆SOFA [Time frame: within the prior 7 days after cardiac surgery.]
Secondary outcome measures (1)
- Plasma interleukin-1 levels [Time frame: within the prior 7 days after cardiac surgery.]
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- The First Affiliated Hospital of Nanjing Medical University — Nanjing
Publications
- Jia P, Ji Q, Zou Z, Zeng Q, Ren T, Chen W, Yan Z, Shen D, Li Y, Peng F, Su Y, Xu J, Shen B, Luo Z, Wang C, Ding X. Effect of Delayed Remote Ischemic Preconditioning on Acute Kidney Injury and Outcomes in Patients Undergoing Cardiac Surgery: A Randomized Clinical Trial. Circulation. 2024 Oct 22;150(17):1366-1376. doi: 10.1161/CIRCULATIONAHA.124.071408. Epub 2024 Sep 25. PMID 39319450
Identifiers
NCT: NCT06707350 · PANDA VII