Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years inclusive.
Written informed consent obtained before participation.
Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional treatment
Procedure/SurgeryBeside 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
DrugThe 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
DrugAn 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.
Treatment groups
236 Participants
are divided into 2 treatment groupsGroup A: Sivelestat groupExperimental treatment 2 interventions
Group B: Control groupPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
Clinical Outcomes - Incidence of tracheotomy
Incidence of tracheotomy
Time frame
from the entry of ICU(baseline, post-operatively) to the 28th day after surgery3
Clinical Outcomes - Re-intubation rate
Re-intubation rate
Time frame
from the entry of ICU(baseline, post-operatively) to the 28th day after surgery4
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 surgeryOther outcomes
1
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Zhongshan Hospital
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborator
Fujian Provincial Hospital
Collaborator
The University of Hong Kong-Shenzhen Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Changhai Hospital
Collaborator
Source ClinicalTrials.gov
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