Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection

Официальное название

Assessment of the Efficacy of Sivelestat Sodium Treatment in Post-operative Organ Dysfunction in Patients With Acute Type A Aortic Dissection (STOP): a Multicenter, Double-blind RCT

Обзор

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

Вмешательства

• Процедура Conventional treatment
  Beside the using of Sivelestat Sodium or placebo, all postoperative care will adhere to each center's standard protocols for type A aortic dissection.
• Препарат Sivelestat sodium
  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.
• Препарат Placebo
  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.

Первичные конечные точки

• ΔSOFA5 [Срок оценки: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)]

Вторичные конечные точки (12)

• AUC - SOFA [Срок оценки: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)]
• Clinical Outcomes - Incidence of tracheotomy [Срок оценки: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
• Clinical Outcomes - Re-intubation rate [Срок оценки: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
• Clinical Outcomes - Gastrointestinal bleeding （count, rate） [Срок оценки: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
• Clinical Outcomes - Infection [Срок оценки: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
• Clinical Outcomes - In-hospital mortality [Срок оценки: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
• Clinical Outcomes - ICU length of stay (days) [Срок оценки: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
• Clinical Outcomes - Total hospital length of stay (days) [Срок оценки: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
• Clinical Outcomes - Ventilator-free days at day 28 (days) [Срок оценки: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
• Clinical Outcomes - Invasive ventilatory support duration at day 28 (days) [Срок оценки: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
• Clinical Outcomes - Respiratory-support-free time at day 28 (days) [Срок оценки: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]
• Clinical Outcomes - Organ-support-free days at day 28(days) [Срок оценки: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 6 центров

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• Fujian Provincial Hospital — Фучжоу
• Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong — Гуанчжоу
• The University of Hong Kong - Shenzhen Hospital — Шэньчжэнь
• The First Affiliated Hospital of Xi'an Jiao Tong University — Сиань
• Changhai Hospital of Shanghai — Шанхай

Идентификаторы

NCT: NCT07156656 · B2025-349R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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