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Treatment of ARDS With Sivelestat Sodium (TOAWSS)

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sivelestat sodium
Saline
Sponsored by
Sichuan Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome

Eligibility Criteria

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

Inclusion Criteria:

  1. Males and females > 18 years old and <75 years old (non-pregnant, non-lactating females).
  2. Patients fulfilled the Berlin diagnostic criteria of acute respiratory distress syndrome, with a arterial oxygen partial pressure (PaO2) to fraction of inspired oxygen (FiO2) between 150 mmHg and 300 mmHg.
  3. Signed written informed consent has been obtained

Exclusion Criteria:

  1. History of chronic respiratory disease
  2. Single cardiogenic pulmonary edema
  3. Apach2 score ≥21 points
  4. Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge
  5. ARDS course>3 days
  6. Agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone>40mg/day)
  7. Pregnancy or breastfeeding
  8. Participated in this study
  9. Do not agree to participate in this experiment

Sites / Locations

  • Sichuan provincial people's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Saline

Sivelestat Sodium

Arm Description

Outcomes

Primary Outcome Measures

oxygenation improvement rate
ventilator free days

Secondary Outcome Measures

Invasive mechanical ventilation rate
length of stay in ICU
length of stay in hospital
28 days mortality
ICU mortality
Incidence of acquired infections
oxygenation improvement rate
oxygenation improvement rate
incidence of severe adverse effect
activity of neutrophil elastase in plasma
activity of neutrophil elastase in plasma
activity of neutrophil elastase in plasma
activity of neutrophil elastase in plasma
concentration of IL-6
concentration of IL-6
concentration of IL-6
concentration of IL-6
concentration of IL-10
concentration of IL-10
concentration of IL-10
concentration of IL-10

Full Information

First Posted
May 20, 2021
Last Updated
April 18, 2022
Sponsor
Sichuan Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04909697
Brief Title
Treatment of ARDS With Sivelestat Sodium
Acronym
TOAWSS
Official Title
Efficacy of Sivelestat Sodium in the Treatment of ARDS With SIRS, a Multicenter Double-blind Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Provincial People's Hospital

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
Neutrophil elastase (NE) released by neutrophils play an important role in inflammatory cascade and lung tissue injury of ARDS.Inhibition of NE is expected to prevent the pathophysiological process of ARDS and alleviate lung injury. Siverestat sodium is a specific inhibitor of NE, which has been proved by basic and observational clinical studies to be effective in alleviating lung injury of ARDS, but there is a lack of prospective multi-center randomized controlled clinical trials.Therefore, this study was intended to evaluate the efficacy of sivelestat sodium in the treatment of ARDS patients with SIRS in a multicenter randomized controlled clinical trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
324 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Sham Comparator
Arm Title
Sivelestat Sodium
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sivelestat sodium
Intervention Description
4.8mg/kg sivelestat sodium was given in 50ml normal saline, and was continuously pumped in the dark for 24h, equivalent to 0.2mg/kg/h.Applied for 5 consecutive days
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days
Primary Outcome Measure Information:
Title
oxygenation improvement rate
Time Frame
day 3
Title
ventilator free days
Time Frame
day 28
Secondary Outcome Measure Information:
Title
Invasive mechanical ventilation rate
Time Frame
day 28
Title
length of stay in ICU
Time Frame
day 28
Title
length of stay in hospital
Time Frame
day 28
Title
28 days mortality
Time Frame
day 28
Title
ICU mortality
Time Frame
day 28
Title
Incidence of acquired infections
Time Frame
day 28
Title
oxygenation improvement rate
Time Frame
day 1
Title
oxygenation improvement rate
Time Frame
day 5
Title
incidence of severe adverse effect
Time Frame
day 28
Title
activity of neutrophil elastase in plasma
Time Frame
day0
Title
activity of neutrophil elastase in plasma
Time Frame
day 1
Title
activity of neutrophil elastase in plasma
Time Frame
day 3
Title
activity of neutrophil elastase in plasma
Time Frame
day 5
Title
concentration of IL-6
Time Frame
day 0
Title
concentration of IL-6
Time Frame
day 1
Title
concentration of IL-6
Time Frame
day 3
Title
concentration of IL-6
Time Frame
day 5
Title
concentration of IL-10
Time Frame
day 0
Title
concentration of IL-10
Time Frame
day 1
Title
concentration of IL-10
Time Frame
day 3
Title
concentration of IL-10
Time Frame
day 5

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: Males and females > 18 years old and <75 years old (non-pregnant, non-lactating females). Patients fulfilled the Berlin diagnostic criteria of acute respiratory distress syndrome, with a arterial oxygen partial pressure (PaO2) to fraction of inspired oxygen (FiO2) between 150 mmHg and 300 mmHg. Signed written informed consent has been obtained Exclusion Criteria: History of chronic respiratory disease Single cardiogenic pulmonary edema Apach2 score ≥21 points Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge ARDS course>3 days Agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone>40mg/day) Pregnancy or breastfeeding Participated in this study Do not agree to participate in this experiment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongli He, Ph.D.
Phone
+86-28-87393633
Email
hhl0408@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaobo Huang, MD
Organizational Affiliation
Sichuan Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sichuan provincial people's hospital
City
Chengdu
State/Province
Sichuan Privince
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongli He, PH. D
Email
hhl0408@163.com

12. IPD Sharing Statement

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Treatment of ARDS With Sivelestat Sodium

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