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NCT Number: NCT07165717

A Real World Study of Respiratory Critical Disease.

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.

Recruiting

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Key information

Conditions

ARDS (Acute Respiratory Distress Syndrome) Acute Lung Injury Lung Diseases Lung Injury Real World Study Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University, Zhong Shan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 meeting the inclusion criteria for a high-risk ARDS population.
  • Patients (or legal representatives) who have provided a signed and dated informed consent form.

Exclusion criteria

  • 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.

Treatment and study plan

No Intervention: Observational Cohort

Other

Obsercational study

Primary outcomes

  1. Mortality

    Time frame: Day 28 after ARDS diagnosis

    Clinical observation

  2. Mortality

    Time frame: Day 60 after ARDS diagnosis

    Clinical observation

Secondary outcomes

  1. Chest CT Scan

    Time frame: Monitored daily

    Chest CT imaging

  2. Complete Blood Count

    Time frame: Monitored daily

    Blood sampling and laboratory testing

  3. Serial Arterial Blood Gas Monitoring

    Time frame: Monitored daily after enrollment

    Arterial blood gas collection

  4. Fluid Input and Output Balance

    Time frame: Whenever fluid input or output occurs

    Clinical nursing records

  5. Mechanical Ventilation Monitoring

    Time frame: Every second after intubation

    Automatically recorded by ventilator

Study contacts

Contact information is provided by the study sponsor or research team.

Yuxian Wang, Doctor

CONTACT

[email protected]

86-13482359545

Sponsors and collaborators

Lead sponsor

Ming Zhong

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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