Efficacy and Safety of Sivelestat Sodium Injection in Ultra-Early Phase Moderately Severe Acute Pancreatitis Complicated by SIRS: A Prospective Open-Label Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500106233

Enrollment

Unknown

Registered

2025-07-21

Start date

2025-07-31

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pancreatitis complicated with systemic inflammatory response syndrome

Interventions

sivelestat group:Sivelestat Sodium for Injection

control group:Conventional treatment group

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age>=18 years old and <=75 years old, regardless of gender 2. Patients admitted to the hospital within 72 hours of the onset of symptoms of pancreatitis 3. Patients diagnosed with moderate to severe acute pancreatitis combined with SIRS 4. Able to understand and comply with the protocol requirements, voluntarily participate in this study, and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients with an estimated survival time of =1mg/kg/d) for a long time (continuous use>=3 weeks). 8. Patients who are participating in other exploratory clinical studies at the same time 9. Use similar drugs such as ulinastatin, Xuebijing, and thymuspeptide at the same time 10. Patients who are allergic or intolerant to sivelestat sodium and related excipients 11. Patients who are judged by the investigator to be unsuitable for participation in this study

Design outcomes

Primary

Measure	Time frame
The change value of the Sequential Organ Failure Assessment (SOFA) score from the baseline;	—

Secondary

Measure	Time frame
The change in SOFA score from baseline during D1-D14 after the first administration (or at the time of transfer out of the ICU/discharge if less than 14 days);The changes from baseline in the modified Marshall score;The changes from baseline in theBedside Index of Severity in Acute Pancreatitis (BISAP),;The changes from baseline in theAcute Physiology and Chronic Health Evaluation II (APACHE II) score;Inflammatory factor levels;blood gas analysis;Time without respiratory support;ventilator-free days;The number of days survived and hospitalized;in-hospital mortality rate;death rate;	—

Measure

Time frame

The change in SOFA score from baseline during D1-D14 after the first administration (or at the time of transfer out of the ICU/discharge if less than 14 days);The changes from baseline in the modified Marshall score;The changes from baseline in theBedside Index of Severity in Acute Pancreatitis (BISAP),;The changes from baseline in theAcute Physiology and Chronic Health Evaluation II (APACHE II) score;Inflammatory factor levels;blood gas analysis;Time without respiratory support;ventilator-free days;The number of days survived and hospitalized;in-hospital mortality rate;death rate;

—

Countries

China

Contacts

Public ContactZhou Yuming

Ganzhou People's Hospital

zhouyuming@mail.gzsrmyy.com+86 138 7977 4789

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026