Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery
ConditionAortic Dissection Type A
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujian Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Remote ischemic preconditioning (RIPC)
Procedure/SurgeryThis 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.
Treatment groups
1,296 Participants
are divided into 2 treatment groupsGroup A: RIPC Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention
Trial outcomes
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.
Time frame
surgery to discharge or 30 days post-opSecondary outcomes
1
Maximum SOFA-2 Score in First 3 Postoperative Days
The highest (peak) SOFA-2 score recorded during the first 3 days following surgery
Time frame
From ICU admission (postoperatively) up to postoperative day 32
Operative Time
Total duration of the surgical procedure from skin incision to skin closure, measured in minutes
Time frame
During the surgical procedure3
Duration of Mechanical Ventilation
Total time from the end of surgery until successful extubation, measured in hours. Re-intubation times are included if applicable
Time frame
From end of surgery until extubation (assessed up to 30 days)4
ICU Length of Stay
Total duration of stay in the Intensive Care Unit after surgery, measured in days
Time frame
From ICU admission after surgery until ICU discharge (assessed up to 30 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fujian Medical University
Lead sponsor
The First Affiliated Hospital of Dalian Medical University
Collaborator
Xiamen Cardiovascular Hospital, Xiamen University
Collaborator
Source ClinicalTrials.gov