Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Remote ischemic preconditioning (RIPC): This intervention is a non-invasive organ-protective procedure. After induction of general anesthesia, remote ischemic preconditioning (RIPC) will be applied to the upper arm and thigh. Both the upper arm and thigh will each undergo four ischemia-reperfusion cycles. Each cycle consists of 5 minutes of cuff inflation at 200 mmHg-or at least 15 mmHg above the systolic blood pressure if the systolic blood pressure exceeds 185 mmHg-to induce ischemia, followed by 5 minutes of cuff deflation to allow reperfusion. The cuff inflation periods at the two sites will be staggered, beginning with the upper arm. The first thigh cuff inflation will begin after completion of the first upper-arm cuff inflation, and the alternating sequence will continue until both sites have completed four cycles. The procedure is intended to activate endogenous protective mechanisms and enhance the tolerance of vital organs to subsequent ischemic injury during surgery.

Study summary

The goal of this clinical trial is to learn if a technique called remote ischemic preconditioning (RIPC) helps protect organs during emergency surgery for acute type A aortic dissection (ATAAD). The main questions it aims to answer are:

Does RIPC reduce the risk of major complications after surgery, such as heart, brain, or kidney problems?

Is RIPC safe to use during emergency ATAAD surgery?

Researchers will compare the RIPC group to a control group (who will receive a placebo) to see if RIPC can reduce complications after surgery.

Participants will:

Receive either RIPC or a sham intervention during their surgery.

Be monitored for up to 30 days after surgery for complications.

Have follow-up visits at 3 months, 1 year, and then yearly for up to 5 years to track their recovery.

Eligibility

Primary outcome measure(s)

• In-hospital major adverse outcomes — surgery to discharge or 30 days post-op
  A composite of major adverse outcomes (binary). Includes: Perioperative all-cause death; Severe post-op complications (Grade III/IV per IAASSG consensus), involving neurological, cardiovascular, respiratory, urinary, gastrointestinal, and other systems.

Trial sites (16)

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