Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis

ARDS Clinical Trial

Official title:

Protective Effect of Sivelestat Sodium on ARDS in Patients With Sepsis: Multicenter, Random, Double-blind, Parallel, Placebo Control Clinical Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04973670
• Other study ID #: ZDHL
• Status: Recruiting
• Phase: Phase 3
• Start date: October 11, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: April 2023
• Source: Southeast University, China
• Contact: Liu ling, MD
• Phone: +86-25-83262552
• Email: liulingdoctor[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: October 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• ARDS
• Sepsis

Intervention

Drug:
• Sivelestat sodium
Sivelestat sodium 0.2mg/kg.h for 1-7 days
• Placebo
The same amount of NS containing only sivelestat sodium excipients

Locations

Country	Name	City	State
China	Nanjing Zhong-Da Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	From study drug administration to days 7
Secondary	Concentration of inflammatory factors on day 1, 3 and 7 from drug administration	Inflammatory factors include Interleukin(IL)-1ß,IL-6, IL-8, IL-10, tumor necrosis factor(TNF)-a	From study drug administration to days 7
Secondary	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	From study drug administration to days 7
Secondary	Platelet count on day 1, 3 and 7 from drug administration	Platelet count was recorded on day 1, 3 and 7 from drug administration	From study drug administration to days 7
Secondary	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	From study drug administration to days 7
Secondary	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	From study drug administration to days 7
Secondary	The 28-day ventilator-free days (VFD)	Days alive and free from mechanical ventilation from study drug administration to day 28	From study drug administration to day 28
Secondary	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	From study drug administration to day 28
Secondary	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.	From study drug administration to day 28
Secondary	Length of hospital stay	The number of days the subject stayed in the hospital	From administration to discharge hospital, up to 90 days
Secondary	The 28-day mortality	Death of any cause from study drug administration to day 28	From study drug administration to day 28
Secondary	The 90-day mortality	Death of any cause from study drug administration to day 90	From study drug administration to day 90