NCT04973670

Brief Summary

Sivelestat sodium has been approved for use in patients with SIRS and ALI, but whether it can protect patients with sepsis from developing ARDS remains unknown.The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
238

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

July 13, 2021

Last Update Submit

April 2, 2023

Conditions

ARDS

Keywords

SepsisRespiratory FailureARDSefficacySivelestat sodium

Outcome Measures

Primary Outcomes (1)

  • Progression to ARDS within 7 days (Berlin criteria)

    The proportion of patients with sepsis progressing to ARDS

    From study drug administration to days 7

Secondary Outcomes (12)

  • Oxygenation index (PaO2/FiO2) or SpO2 / FiO2 on day 1, 3 and 7 from drug administration

    From study drug administration to days 7

  • Concentration of inflammatory factors on day 1, 3 and 7 from drug administration

    From study drug administration to days 7

  • Concentration of neutrophil elastase on day 1, 3 and 7 from drug administration

    From study drug administration to days 7

  • Platelet count on day 1, 3 and 7 from drug administration

    From study drug administration to days 7

  • Concentration of C-reactive protein on day 1, 3 and 7 from drug administration

    From study drug administration to days 7

  • +7 more secondary outcomes

Study Arms (2)

Sivelestat sodium

EXPERIMENTAL

Sivelestat sodium 0.2mg/kg.h

Drug: Sivelestat sodium

placebo

ACTIVE COMPARATOR

The same amount of NS containing only sivelestat sodium excipients

Drug: Placebo

Interventions

Sivelestat sodiumDRUG

Sivelestat sodium 0.2mg/kg.h for 1-7 days

Sivelestat sodium
PlaceboDRUG

The same amount of NS containing only sivelestat sodium excipients

placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Within 24 hours after admission, sepsis 3.0 diagnostic criteria were met;
  • The patients or their family members fully understand the purpose and significance of the trial, voluntarily participate in the clinical trial, and sign the informed consent.

You may not qualify if:

  • Patients with ARDS were identified at the time of admission;
  • Patients who explicitly refused mechanical ventilation;
  • Patients with 3 or more extrapulmonary organ injuries and organ failure(single organ SOFA score ≥ 3);
  • Patients who need home oxygen therapy or with home mechanical ventilation (by tracheotomy or noninvasive ventilation, but excluding CPAP / BiPAP, only for patients with obstructive sleep apnea);
  • The patient whose expected survival time was less than 48 hours;
  • Pregnant women and lactating women;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Zhong-Da Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Related Publications (1)

  • Ma S, Li C, Gao Z, Xie J, Qiu H, Yang Y, Liu L. Effects of intravenous sivelestat sodium on prevention of acute respiratory distress syndrome in patients with sepsis: study protocol for a double-blind multicentre randomised controlled trial. BMJ Open. 2023 Sep 13;13(9):e074756. doi: 10.1136/bmjopen-2023-074756.

    PMID: 37709320DERIVED

MeSH Terms

Conditions

SepsisRespiratory Insufficiency

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Liu ling, MD

    Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

    STUDY CHAIR

Central Study Contacts

Liu ling, MD

CONTACT

+86-25-83262552liulingdoctor@126.com

Yang yi, MD

CONTACT

+86-25-83262552yiyiyang2004@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 22, 2021

Study Start

October 11, 2021

Primary Completion

September 30, 2023

Study Completion

October 30, 2023

Last Updated

April 5, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)