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;
Acute type A aortic dissection requiring emergency surgery within 14 days of symptom onset;
Written informed consent provided by the participant or a legally authorized representative;
Willingness to comply with study follow-up.
Disqualifiers
Traumatic or iatrogenic aortic dissection;
Previous open cardiac or thoracic aortic surgery;
Persistent deep coma (Glasgow Coma Scale score ≤8), abdominal compartment syndrome, preoperative mechanical circulatory support, or norepinephrine-equivalent dose >0.1 μg/kg/min;
Estimated glomerular filtration rate <30 mL/min/1.73 m², total bilirubin >342 μmol/L, or international normalized ratio >2.0;
Trial design
Design model
Parallel
Treatments tested in this trial
Remote ischemic preconditioning (RIPC)
Procedure/SurgeryThis 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.
Treatment groups
1,312 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
Sequential Organ Failure Assessment (SOFA) Score Within the First 3 Postoperative Days
The Sequential Organ Failure Assessment (SOFA) score evaluates dysfunction across six organ systems: brain, respiratory, cardiovascular, liver, kidney, and hemostasis. Each organ system is scored from 0 to 4, yielding a total score ranging from 0 to 24. Higher scores indicate more severe organ dysfunction and a worse outcome. SOFA scores will be recorded within the first 3 postoperative days.
Time frame
From postoperative ICU admission through postoperative day 32
Operative Time
Operative and cardiopulmonary bypass-related time parameters, including total operative duration, cardiopulmonary bypass duration, aortic cross-clamp duration, and circulatory arrest duration. All durations will be 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 hours
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
Xiamen Cardiovascular Hospital, Xiamen University
Collaborator
The First Affiliated Hospital of Dalian Medical University
Collaborator
Henan Provincial Chest Hospital
Collaborator
RenJi Hospital
Collaborator
Shengjing Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
Qilu Hospital of Shandong University
Collaborator
Xinqiao Hospital, Amry Medical University
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
Yan'an Affiliated Hospital of Kunming Medical University
Collaborator
The Fourth Affiliated Hospital of Harbin Medical University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
Source ClinicalTrials.gov