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Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis

Primary Purpose

ARDS

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sivelestat sodium
Placebo
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ARDS focused on measuring Sepsis, Respiratory Failure, ARDS, efficacy, Sivelestat sodium

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Other conditions judged by the researcher not suitable for inclusion.

Sites / Locations

  • Nanjing Zhong-Da Hospital, Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sivelestat sodium

placebo

Arm Description

Sivelestat sodium 0.2mg/kg.h

The same amount of NS containing only sivelestat sodium excipients

Outcomes

Primary Outcome Measures

Progression to ARDS within 7 days (Berlin criteria)
The proportion of patients with sepsis progressing to ARDS

Secondary Outcome Measures

Oxygenation index (PaO2/FiO2) or SpO2 / FiO2 on day 1, 3 and 7 from drug administration
PaO2/FiO2 or SpO2 / FiO2 was recorded on day 1, 3 and 7 from drug administration
Concentration of inflammatory factors on day 1, 3 and 7 from drug administration
Inflammatory factors include Interleukin(IL)-1β,IL-6, IL-8, IL-10, tumor necrosis factor(TNF)-α
Concentration of neutrophil elastase on day 1, 3 and 7 from drug administration
Concentration of neutrophil elastase was recorded on day 1, 3 and 7 from drug administration
Platelet count on day 1, 3 and 7 from drug administration
Platelet count was recorded on day 1, 3 and 7 from drug administration
Concentration of C-reactive protein on day 1, 3 and 7 from drug administration
Concentration of High sensitivity C-reactive protein was recorded on day 1, 3 and 7 from drug administration
Sequential organ failure assessment (SOFA) score on day 1, 3 and 7 from drug administration
The SOFA scores on day 1, 3 and 7 were recorded
The 28-day ventilator-free days (VFD)
Days alive and free from mechanical ventilation from study drug administration to day 28
The 28-day shock-free days
Days alive and free from vasopressor support which define as infusion of any vasopressor/inotrope agent for a minimum of 1 hour (i.e.norepinephrine, epinephrine, phenylephrine, vasopressin analogues, angiotensin, dopamine, dobutamine, milrinone or levosimendan) from study drug administration to day 28
The 28-day time to clinical improvement
Defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first. The seven-category ordinal scale consisted of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7, death.
Length of hospital stay
The number of days the subject stayed in the hospital
The 28-day mortality
Death of any cause from study drug administration to day 28
The 90-day mortality
Death of any cause from study drug administration to day 90

Full Information

First Posted
July 13, 2021
Last Updated
April 2, 2023
Sponsor
Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT04973670
Brief Title
Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis
Official Title
Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis: Multicenter, Random, Double-blind, Parallel, Placebo Control Clinical Trials
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study was conducted in accordance with good clinical practice and with the guidelines set out in the Declaration of Helsinki. After approval from local and national ethics committees, patients from 3 centers in China were recruited. All patients were randomized, in a double-blind manner, to receive either sivelestat sodium regimen or a placebo regimen for 1- 7 days in ICU. The aim of this study was to determine whether sivelestat sodium has a protective effect on ARDS in patients with sepsis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS
Keywords
Sepsis, Respiratory Failure, ARDS, efficacy, Sivelestat sodium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
238 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sivelestat sodium
Arm Type
Experimental
Arm Description
Sivelestat sodium 0.2mg/kg.h
Arm Title
placebo
Arm Type
Active Comparator
Arm Description
The same amount of NS containing only sivelestat sodium excipients
Intervention Type
Drug
Intervention Name(s)
Sivelestat sodium
Intervention Description
Sivelestat sodium 0.2mg/kg.h for 1-7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The same amount of NS containing only sivelestat sodium excipients
Primary Outcome Measure Information:
Title
Progression to ARDS within 7 days (Berlin criteria)
Description
The proportion of patients with sepsis progressing to ARDS
Time Frame
From study drug administration to days 7
Secondary Outcome Measure Information:
Title
Oxygenation index (PaO2/FiO2) or SpO2 / FiO2 on day 1, 3 and 7 from drug administration
Description
PaO2/FiO2 or SpO2 / FiO2 was recorded on day 1, 3 and 7 from drug administration
Time Frame
From study drug administration to days 7
Title
Concentration of inflammatory factors on day 1, 3 and 7 from drug administration
Description
Inflammatory factors include Interleukin(IL)-1β,IL-6, IL-8, IL-10, tumor necrosis factor(TNF)-α
Time Frame
From study drug administration to days 7
Title
Concentration of neutrophil elastase on day 1, 3 and 7 from drug administration
Description
Concentration of neutrophil elastase was recorded on day 1, 3 and 7 from drug administration
Time Frame
From study drug administration to days 7
Title
Platelet count on day 1, 3 and 7 from drug administration
Description
Platelet count was recorded on day 1, 3 and 7 from drug administration
Time Frame
From study drug administration to days 7
Title
Concentration of C-reactive protein on day 1, 3 and 7 from drug administration
Description
Concentration of High sensitivity C-reactive protein was recorded on day 1, 3 and 7 from drug administration
Time Frame
From study drug administration to days 7
Title
Sequential organ failure assessment (SOFA) score on day 1, 3 and 7 from drug administration
Description
The SOFA scores on day 1, 3 and 7 were recorded
Time Frame
From study drug administration to days 7
Title
The 28-day ventilator-free days (VFD)
Description
Days alive and free from mechanical ventilation from study drug administration to day 28
Time Frame
From study drug administration to day 28
Title
The 28-day shock-free days
Description
Days alive and free from vasopressor support which define as infusion of any vasopressor/inotrope agent for a minimum of 1 hour (i.e.norepinephrine, epinephrine, phenylephrine, vasopressin analogues, angiotensin, dopamine, dobutamine, milrinone or levosimendan) from study drug administration to day 28
Time Frame
From study drug administration to day 28
Title
The 28-day time to clinical improvement
Description
Defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first. The seven-category ordinal scale consisted of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7, death.
Time Frame
From study drug administration to day 28
Title
Length of hospital stay
Description
The number of days the subject stayed in the hospital
Time Frame
From administration to discharge hospital, up to 90 days
Title
The 28-day mortality
Description
Death of any cause from study drug administration to day 28
Time Frame
From study drug administration to day 28
Title
The 90-day mortality
Description
Death of any cause from study drug administration to day 90
Time Frame
From study drug administration to day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; Other conditions judged by the researcher not suitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu ling, MD
Phone
+86-25-83262552
Email
liulingdoctor@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yang yi, MD
Phone
+86-25-83262552
Email
yiyiyang2004@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu ling, MD
Organizational Affiliation
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing Zhong-Da Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Liu, pHd
Phone
+86-25-83262550
Email
liulingdoctor@gmail.com
First Name & Middle Initial & Last Name & Degree
Yang Yi, pHd
Phone
+86-25-83262552
Email
yiyiyang2004@gmail.com
First Name & Middle Initial & Last Name & Degree
Ling Liu, pHd

12. IPD Sharing Statement

Plan to Share IPD
No

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Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis

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