A Phase 4 interventional study of Conventional treatment and Sivelestat sodium in Type A Aortic Dissection and Organ Failure, Multiple, sponsored by Shanghai Zhongshan Hospital. Recruiting at 7 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Shanghai Zhongshan Hospital · Phase 4, Interventional, and Treatment
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:
193 studies on the registry are indexed under Multiple Organ Failure; 47 are open to participants now.
This study's planned enrollment of 236 is above the median of 88 across 90 interventional studies indexed under Multiple Organ Failure.
Browse Multiple Organ Failure studies →Shanghai Zhongshan Hospital is the lead sponsor of 652 studies on the registry; 291 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Sivelestat Sodium. Procedure: Conventional Treatment
Procedure: Conventional treatment · Drug: Sivelestat sodium
Drug: Placebo. Procedure: Conventional Treatment
Procedure: Conventional treatment · Drug: Placebo
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.
Also known as: Siv
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.
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)
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).
Time frame: from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Jan 2027, 16 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Sep 2028 → Jan 2027 and completion Sep 2028 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sivelestat sodium tetrahydrate