Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery

NCT07383909 | Recruiting

• 1 other identifier: A202601
• Study Type: interventional
• Target: 1,296
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Aortic Dissection Type A

Keywords

Remote Ischaemic Conditioning; ischemia reperfusion injury; emergency surgery; major adverse outcomes

Outcome Measures

Primary Outcomes (1)

• In-hospital major adverse outcomes

  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.

  surgery to discharge or 30 days post-op

Secondary Outcomes (11)

• Maximum SOFA-2 Score in First 3 Postoperative Days

  From ICU admission (postoperatively) up to postoperative day 3

• Operative Time

  During the surgical procedure

• Duration of Mechanical Ventilation

  From end of surgery until extubation (assessed up to 30 days)

• ICU Length of Stay

  From ICU admission after surgery until ICU discharge (assessed up to 30 days)

• Hospital Length of Stay

  From hospital admission for surgery until hospital discharge (assessed up to 30 days)

Study Arms (2)

RIPC Intervention Group

EXPERIMENTAL

Participants randomized to this group will receive remote ischemic preconditioning (RIPC). After induction of general anesthesia, RIPC will be applied to the upper arm and thigh on the non-arterial cannulation side. The procedure consists of four alternating ischemia-reperfusion cycles, each cycle comprising 5 minutes of cuff inflation (at 200 mmHg, or systolic blood pressure +15 mmHg if systolic blood pressure exceeds 185 mmHg), followed by 5 minutes of cuff deflation for reperfusion. The inflation process alternates, starting with the upper arm. The thigh cuff inflation will begin only after the first upper arm inflation cycle is completed, and this process will repeat in alternating cycles.

Procedure: Remote ischemic preconditioning (RIPC)

Control Group

SHAM COMPARATOR

Participants randomized to this group will receive a sham RIPC procedure. The same cuff placement and timing as the experimental group are used, but the cuff is inflated to only 20 mmHg for 5 minutes followed by 5 minutes of deflation, simulating the RIPC procedure without inducing ischemia.

Procedure: Remote ischemic preconditioning (RIPC)

Interventions

Remote ischemic preconditioning (RIPC) PROCEDURE

This intervention is a non-invasive organ protection procedure. After induction of general anesthesia, 4 cycles of remote ischemic preconditioning (RIPC) are applied to the upper arm and thigh on the non-arterial cannulation side. Each cycle consists of 5 minutes of cuff inflation (at 200 mmHg, or systolic blood pressure +15 mmHg if systolic blood pressure exceeds 185 mmHg) to induce ischemia, followed by 5 minutes of cuff deflation for reperfusion. To ensure safety, the cuff inflation cycles alternate between the upper arm and thigh. The procedure aims to activate endogenous protective mechanisms, enhancing the tolerance of vital organs to subsequent ischemic injury during surgery.

Control Group; RIPC Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, with no restriction on sex;
• Diagnosis of acute Type A aortic dissection requiring emergency surgery (symptom onset \<14 days);
• Ability to understand the study objectives, voluntary provision of written informed consent by the patient or a legally authorized representative, and willingness to comply with follow-up.

You may not qualify if:

• Traumatic or iatrogenic aortic dissection;
• Previous open cardiac or thoracic aortic surgery;
• Severe preoperative dysfunction of vital organs, such as persistent deep coma, abdominal compartment syndrome, or circulatory failure;
• Severe comorbidities, including myocardial infarction within the past 7 days, stroke within the past 2 months; end-stage renal disease (eGFR \<30 ml/min/1.73 m²); end-stage liver disease (total bilirubin \>342 μmol/L or INR \>2.0);
• Evidence of ischemia in the limb planned for intervention, such as decreased skin temperature, pain, pallor, with or without sensory disturbance, paralysis, or diminished/absent pulses; or severe deformity or prior arteriovenous surgery at the intervention site;
• Peripheral arterial disease involving the limbs, Raynaud phenomenon, active phlebitis, or a history of deep vein thrombosis of the lower extremities;
• Current use of sulfonylurea oral hypoglycemic agents or nicorandil;
• Life expectancy \<1 year (e.g., advanced malignancy);
• Participation in another clinical trial without having reached its primary endpoint;
• Pregnancy or lactation; immunodeficiency (e.g., HIV positivity, history of organ transplantation); known bleeding disorders, coagulation abnormalities, or sickle cell anemia; active or uncontrolled infection;
• Other severe physical or psychiatric disorders, or laboratory abnormalities, which in the investigator's judgment may increase risk or interfere with study outcomes, rendering the patient unsuitable for enrollment.

Sponsors & Collaborators

• Fujian Medical University: lead
• Xiamen Cardiovascular Hospital, Xiamen University: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator

Study Sites (3)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Xiamen Cardiovascular Hospital, Xiamen University

Xiamen, Fujian, China

NOT YET RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

NOT YET RECRUITING

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liang-wan Chen, M.D Ph.D

CONTACT

+8613358255333; chenliangwan@fjmu.edu.cn

Xin-fan Lin, M.D

CONTACT

+8617850019550; lxf1885@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: February 3, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): December 31, 2032
• Last Updated: February 3, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)