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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
236
Beside the using of Sivelestat Sodium or placebo, all postoperative care will adhere to each center's standard protocols for type A aortic dissection.
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.
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.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University)
Guangzhou, Guangdong, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
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.
Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)
AUC - SOFA
Area under the SOFA-time curve
Time frame: 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
Incidence of tracheotomy
Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Re-intubation rate
Re-intubation rate
Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - Gastrointestinal bleeding （count, rate）
Gastrointestinal bleeding （count, rate）
Time frame: 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
Time frame: from the entry of ICU(baseline, post-operatively) to the 28th day after surgery
Clinical Outcomes - In-hospital mortality
In-hospital mortality
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)
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