NCT07165717

Brief Summary

Acute Respiratory Distress Syndrome (ARDS) is a form of acute diffuse lung injury caused by various etiologies, which rapidly progresses to acute respiratory failure. It is characterized by a sudden onset and severe clinical course. Globally, ARDS affects approximately 3 million individuals each year, accounting for about 10% of admissions to intensive care units (ICUs). Due to the lack of specific pharmacological therapies, mechanical ventilation remains the mainstay of treatment. Therefore, identifying and analyzing prognostic factors for ARDS patients is of great significance for improving patient outcomes and reducing the incidence of poor prognosis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

6.4 years

First QC Date

June 13, 2025

Last Update Submit

September 2, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mortality

    Clinical observation

    Day 28 after ARDS diagnosis

  • Mortality

    Clinical observation

    Day 60 after ARDS diagnosis

Secondary Outcomes (5)

  • Chest CT Scan

    Monitored daily

  • Complete Blood Count

    Monitored daily

  • Serial Arterial Blood Gas Monitoring

    Monitored daily after enrollment

  • Fluid Input and Output Balance

    Whenever fluid input or output occurs

  • Mechanical Ventilation Monitoring

    Every second after intubation

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients identified as high risk for ARDS after ICU admission.

You may qualify if:

  • Patients with underlying diseases associated with high risk of ARDS, including but not limited to: sepsis, pneumonia, multiple trauma, pulmonary contusion, inhalation injury, massive blood transfusion, other high-risk conditions, or other factors causing excessive respiratory drive.
  • Patients (or legal representatives) who have provided a signed and dated informed consent form.

You may not qualify if:

  • Age under 18 years.
  • HIV infection.
  • Known immunodeficiency disorders (e.g., leukemia, common variable immunodeficiency, etc.).
  • History of solid organ or bone marrow transplantation.
  • Receiving treatment with G-CSF or GM-CSF.
  • Patients with a decision to withdraw from active treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University, Zhong Shan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

June 13, 2025

First Posted

September 10, 2025

Study Start

March 1, 2019

Primary Completion

July 31, 2025

Study Completion

December 31, 2025

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Locations