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| Name | Class |
|---|---|
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Fujian Provincial Hospital | OTHER |
| The University of Hong Kong-Shenzhen Hospital | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sivelestat group | Experimental | Drug: Sivelestat Sodium. Procedure: Conventional Treatment |
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| Control group | Placebo Comparator | Drug: Placebo. Procedure: Conventional Treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ΔSOFA5 | 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. | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC - SOFA | Area under the SOFA-time curve | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma neutrophil elastase levels (exploratory outcome) | Plasma concentration of neutrophil elastase at 1day, 3day and 5day after the first dose in 40 participants enrolled at the main center (20 per arm). | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guowei Tu | Contact | 86 + 13501996995 | tu.guowei@zs-hospital.sh.cn | |
| Chenxu Lin | Contact | 86 + 18016402139 | chenxu_lin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhe Luo | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
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| ID | Term |
|---|---|
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| First Affiliated Hospital Xi'an Jiaotong University |
| OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| Changhai Hospital | OTHER |
a Multicenter, Double-blind RCT
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| 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. |
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| 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. |
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Incidence of tracheotomy
| from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - Re-intubation rate | Re-intubation rate | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - Gastrointestinal bleeding （count, rate） | Gastrointestinal bleeding （count, rate） | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - Infection | Infection: Serious infections such as bloodstream infections, sepsis, ventilator-associated pneumonia | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - In-hospital mortality | In-hospital mortality | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - ICU length of stay (days) | ICU length of stay (days) | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - Total hospital length of stay (days) | Total hospital length of stay (days) | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - Ventilator-free days at day 28 (days) | Mechanical ventilation includes: invasive mechanical ventilation and non-invasive mechanical ventilation | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - Invasive ventilatory support duration at day 28 (days) | Invasive ventilatory support: invasive mechanical ventilation | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - Respiratory-support-free time at day 28 (days) | Respiratory support includes: invasive mechanical ventilation, non-invasive mechanical ventilation, and high-flow oxygen | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - Organ-support-free days at day 28(days) | days free of mechanical ventilation, vasopressors, and renal-replacement therapy | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - Central nervous system complications during ICU stay | Central nervous system complications during ICU stay: cerebral infarction, intracranial hemorrhage, hypoxic-ischemic encephalopathy | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - Delirium incidence during ICU stay | Delirium incidence during ICU stay | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Clinical Outcomes - Incidence of acute kidney injury (AKI) | Incidence of acute kidney injury (AKI) | from the entry of ICU(baseline, post-operatively) to the 28th day after surgery |
| Laboratory Test Results - Arterial blood gas: pH | pH result from arterial blood gas | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Arterial blood gas: PaO₂/FiO₂ | PaO₂/FiO₂ result from arterial blood gas | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Arterial blood gas: SpO₂/FiO₂ | SpO₂/FiO₂ result from arterial blood gas | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Arterial blood gas: PaO₂ | PaO₂ result from arterial blood gas | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Arterial blood gas: PaCO₂ | PaCO₂ result from arterial blood gas | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Arterial blood gas: SpO₂ | SpO₂ result from arterial blood gas | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Arterial blood gas: lactate | lactate result from arterial blood gas | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Liver & kidney function: AST | AST from Liver & kidney function | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Liver & kidney function: ALT | ALT from Liver & kidney function | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Liver & kidney function: ALP | ALP from Liver & kidney function | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Liver & kidney function: GGT | GGT from Liver & kidney function | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Liver & kidney function: TBil | TBil from Liver & kidney function | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Liver & kidney function: DBIL | DBIL from Liver & kidney function | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Liver & kidney function: ALB | ALB from Liver & kidney function | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Liver & kidney function: Scr | Scr from Liver & kidney function | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Liver & kidney function: BUN | BUN from Liver & kidney function | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Liver & kidney function: eGFR | eGFR from Liver & kidney function | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Liver & kidney function: NGAL | NGAL from Liver & kidney function | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Myocardial injury: CK-MB | CK-MB from Myocardial injury | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Myocardial injury: LDH | LDH from Myocardial injury | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Myocardial injury: cTnI or cTnT | cTnI or cTnT from Myocardial injury | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Myocardial injury: BNP or NT-proBNP | BNP or NT-proBNP from Myocardial injury | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Brain injury: NSE | NSE result from blood test, Brain injury part | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Inflammation: CRP | CRP result from Inflammation test | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Inflammation: PCT | PCT result from Inflammation test | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Inflammation: IL-6 | IL-6 result from Inflammation test8 | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Inflammation: IL-8 | IL-8 result from Inflammation test | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Inflammation: IL-10 | IL-10 result from Inflammation test | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Laboratory Test Results - Inflammation: TNF-α | TNF-α result from Inflammation test | from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment) |
| Fujian Provincial Hospital | Fuzhou | Fujian | China |
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| Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University) | Guangzhou | Guangdong | China |
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| The University of Hong Kong - Shenzhen Hospital | Shenzhen | Guangdong | China |
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| The First Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | Shaanxi | China |
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| Changhai Hospital of Shanghai | Shanghai | Shanghai Municipality | China |
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