Effect of Early Treatment With Sivelestat Sodium in ARDS Patients (siv-ARDS)

December 19, 2022 updated by: Nanfang Hospital of Southern Medical University

Effect of Early Treatment With Sivelestat Sodium on Lung Function and Inflammatory Response of ARDS Patients

This study is a multicenter, prospective, observational cohort study. The subjects were patients who developed ARDS within the preceding 72h. They were divided into 2 groups based on the use of sivelestat sodium which was determined by the physician in charge based on the condition of the patients: sivelestat sodium group and conventional treatment group. 560 patients were planned to be enrolled, with 280 patients in each group. In the sivelestat sodium group, patients were treated with sivelestat sodium within 72h of the diagnosis of ARDS. After 5 days of sivelestat treatment, sivelestat treatment should be stopped if the oxygenation index is greater than 300mmHg for at least 3 consecutive times; otherwise, sivelestat treatment should be continued until the oxygenation index is greater than 300mmHg for at least 3 consecutive times; if sivelestat treatment is continued until the 14th day, the drug should be stopped regardless of the oxygenation situation. Baseline data and Murray lung injury score, inflammatory markers, routine test results, duration of ECMO use/length of hospital stay/length of ICU stay were recorded at 1, 3,5, and 7 days after patients were enrolled, and patients were followed up on the 28th and 90th days.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
560

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China, 510515
        • Southern medical university Nanfang hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients developed ARDS in the preceding 72h

Description

Inclusion Criteria:

  • Voluntarily signed informed consent;
  • ≥18 years old;
  • Patients developed ARDS in the preceding 72h;
  • The total scores of the Murray lung injury scores were greater than 6 （When lung compliance was not measured, the total scores of the other three scores were greater than 4）;

Exclusion Criteria:

  • Pregnancy or lactation;
  • ARDS was diagnosed for more than 72 hours;
  • Sivelestat sodium was used for treatment prior to enrollment;
  • Patients with more than 3 extra-pulmonary organ injuries/failure;
  • Severe chronic liver disease (Child-pugh grade C);
  • Previous history of allergy to sivelestat sodium or any of its ingredients or preservatives;
  • Patients whose primary disease cannot be effectively controlled;
  • Patients judged by the investigator to be unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sivelestat Sodium group
Patients treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.
Drug: Sivelestat sodium
Patients were treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.
Conventional treatment group
Patients not treated with Sivelestat Sodium/Normal Saline after the diagnosis of ARDS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Murray lung injury score
Time Frame: change from admission to 7 days after enrollment

The Lung Injury Score can be used to assess the adult patient for the extent of acute pulmonary damage. It can be used both at the onset of a lung disorder and during the course of the illness to monitor changing lung involvement.

Parameters

  • chest X-ray evaluated for alveolar consolidation
  • ratio of the partial pressure of oxygen in arterial blood to the inspiratory fraction of oxygen
  • PEEP level if ventilated
  • respiratory compliance if known
change from admission to 7 days after enrollment
The serum levels of IL-6
Time Frame: change from admission to 7 days after enrollment
change from admission to 7 days after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Capillary leakage index
Time Frame: change from admission to 7 days after enrollment
Ultrasound lung water score, capillary leakage index
change from admission to 7 days after enrollment
Serum levels of leukocytes
Time Frame: change from admission to 7 days after enrollment
change from admission to 7 days after enrollment
Serum electrolyte level
Time Frame: change from admission to 7 days after enrollment
change from admission to 7 days after enrollment
renal function
Time Frame: change from admission to 7 days after enrollment
The serum levels of creatinine
change from admission to 7 days after enrollment
liver function
Time Frame: change from admission to 7 days after enrollment
The serum levels of ALTand AST
change from admission to 7 days after enrollment
myocardial injury indexes
Time Frame: change from admission to 7 days after enrollment
The serum levels of cTnT, CK-MB
change from admission to 7 days after enrollment
respiratory function
Time Frame: change from admission to 7 days after enrollment
oxygenation index
change from admission to 7 days after enrollment
infection and immunity
Time Frame: change from admission to 7 days after enrollment
The serum levels of CRP
change from admission to 7 days after enrollment
infection and immunity
Time Frame: change from admission to 7 days after enrollment
The serum levels of PCT
change from admission to 7 days after enrollment
infection and immunity
Time Frame: change from admission to 7 days after enrollment
The serum levels of IL-10 and IL-1β
change from admission to 7 days after enrollment
infection and immunity
Time Frame: change from admission to 7 days after enrollment
The serum levels of TNF-α
change from admission to 7 days after enrollment
coagulation function
Time Frame: change from admission to 7 days after enrollment
The serum levels of APTT, PT, TT
change from admission to 7 days after enrollment
coagulation function
Time Frame: change from admission to 7 days after enrollment
The serum levels of INR
change from admission to 7 days after enrollment
coagulation function
Time Frame: change from admission to 7 days after enrollment
The serum levels of Fbg
change from admission to 7 days after enrollment
Incidence of new organ insufficiency/failure after enrollment
Time Frame: up to 2 years
up to 2 years
length of ventilation/length of hospital stay/length of ICU stay
Time Frame: up to 2 years
up to 2 years
Mortality rate of in-hospital /28d/90d
Time Frame: 90 days after admission
90 days after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital of Southern Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guangdong No.2 Provincial People's Hospital
Foshan Hospital of Traditional Chinese Medicine
Shenzhen Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFEC-2021-187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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