RecruitingNCT07156656ClinicalTrials.gov record

Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection

Type A Aortic Dissection · Organ Failure, Multiple

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 4
Age range: 18 years - 75 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 236 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The goal of this multicenter, double-blind, randomized controlled trial is to learn if sivelestat sodium (Siv) can protect the organ function in patients suffered operation for acute type A aortic dissection. The main questions it aims to answer are:

Can the 3-day-treatment of Siv enlarge the Day-0-to-Day-5 drop in the organ-health score (SOFA score)?
Can this treatment significantly shrink the area under the SOFA curve from first dose to Day 5?
Can this treatment significantly improve the end of patients in 28 days (clinical outcomes)? Researchers will compare drug Siv to a placebo (a look-alike substance that contains no drug) to see if drug Siv works.

Participants will:

Take drug Siv or the placebo through vein continuously for 72 hours
Receiving regular intensive care in ICU after the operation

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Age 18-75 years inclusive.
2. Written informed consent obtained before participation.
3. Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.

Exclusion Criteria:

1. Life expectancy ≤ 48 hours.
2. Pregnant or lactation.
3. Severe pre-operative liver dysfunction: Child-Turcotte-Pugh score 10-15.
4. Severe pre-operative renal dysfunction: acute or chronic kidney injury meeting criteria for renal-replacement therapy.
5. Confirmed COPD or asthma.
6. Immunosuppression: long-term or \> 2 weeks continuous systemic corticosteroids.
7. Concomitant or anticipated use of immunomodulators (Xue-Bi-Jing injection, thymosin, IVIG).
8. Medical or psychological condition that would interfere with study participation, assessment, or outcomes.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Quadruple masked

Sivelestat group

Drug: Sivelestat Sodium. Procedure: Conventional Treatment

Procedure: Conventional treatment · Drug: Sivelestat sodium

Control group

Drug: Placebo. Procedure: Conventional Treatment

Procedure: Conventional treatment · Drug: Placebo

Conventional treatment PROCEDURE

Beside the using of Sivelestat Sodium or placebo, all postoperative care will adhere to each center's standard protocols for type A aortic dissection.

Sivelestat sodium DRUG

The daily dose (4.8 mg/kg) is diluted in 48 mL of 0.9 % saline and administered as a continuous intravenous infusion over 24 hours at 2 mL/h (equivalent to 0.2 mg/kg/h) for 72 consecutive hours.

Placebo DRUG

An equal volume of placebo-containing only the excipients of sivelestat sodium and diluted to 48 mL with 0.9 % saline-will be infused at 2 mL/h for 72 consecutive hours.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

ΔSOFA5

Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)

ΔSOFA5 is defined as the decrease level of SOFA(Sequential Organ Failure Assessment) score from baseline to the fifth day. SOFA score ranges from 0\~24, the higher the score, the poorer the functionality of multiple organs.

Secondary measures

AUC - SOFA

Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)

Area under the SOFA-time curve

Clinical Outcomes - Incidence of tracheotomy

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

Incidence of tracheotomy

Clinical Outcomes - Re-intubation rate

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

Re-intubation rate

Clinical Outcomes - Gastrointestinal bleeding （count, rate）

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

Gastrointestinal bleeding （count, rate）

Clinical Outcomes - Infection

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

Infection: Serious infections such as bloodstream infections, sepsis, ventilator-associated pneumonia

Clinical Outcomes - In-hospital mortality

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

In-hospital mortality

Clinical Outcomes - ICU length of stay (days)

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

ICU length of stay (days)

Clinical Outcomes - Total hospital length of stay (days)

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

Total hospital length of stay (days)

Clinical Outcomes - Ventilator-free days at day 28 (days)

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

Mechanical ventilation includes: invasive mechanical ventilation and non-invasive mechanical ventilation

Clinical Outcomes - Invasive ventilatory support duration at day 28 (days)

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

Invasive ventilatory support: invasive mechanical ventilation

Clinical Outcomes - Respiratory-support-free time at day 28 (days)

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

Respiratory support includes: invasive mechanical ventilation, non-invasive mechanical ventilation, and high-flow oxygen

Clinical Outcomes - Organ-support-free days at day 28(days)

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

days free of mechanical ventilation, vasopressors, and renal-replacement therapy

Clinical Outcomes - Central nervous system complications during ICU stay

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

Central nervous system complications during ICU stay: cerebral infarction, intracranial hemorrhage, hypoxic-ischemic encephalopathy

Clinical Outcomes - Delirium incidence during ICU stay

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

Delirium incidence during ICU stay

Clinical Outcomes - Incidence of acute kidney injury (AKI)

Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery

Incidence of acute kidney injury (AKI)

Laboratory Test Results - Arterial blood gas: pH