Real-world look at severe respiratory failure (ARDS)
A Real World Study of Respiratory Critical Disease.
This project will collect real-world data on adults at high risk for ARDS to see which clinical factors predict worse outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07165717 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort at Fudan University Zhong Shan Hospital enrolling adult patients who are at high risk for developing ARDS (for example from sepsis, pneumonia, major trauma, pulmonary contusion, inhalation injury, or massive transfusion). No experimental treatments are given; clinical data, treatments (including mechanical ventilation), and outcomes will be recorded to identify prognostic factors. Patients under 18, those with HIV, known immunodeficiency, prior organ or bone marrow transplant, those receiving G-CSF/GM-CSF, or those who have decided to withdraw active treatment are excluded. The goal is to use real-world hospital data to refine risk prediction and inform care strategies that could reduce poor outcomes in ARDS.
Who should consider this trial
Good fit: Adults hospitalized with conditions that put them at high risk for ARDS (such as sepsis, pneumonia, major trauma, pulmonary contusion, inhalation injury, or massive transfusion) who can provide informed consent are ideal candidates.
Not a fit: Children under 18, people with HIV or other known immunodeficiencies, transplant recipients, patients receiving G-CSF/GM-CSF, or those who have chosen to stop active treatment are excluded and unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the findings could help clinicians spot patients most likely to worsen so they can tailor monitoring and treatments sooner.
How similar studies have performed: Previous large observational ARDS cohorts have successfully identified prognostic factors and informed clinical practices, though local real-world data from this center may add region-specific insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University, Zhong Shan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yuxian Wang, Doctor
- Email: wang.yuxian@zs-hospital.sh.cn
- Phone: 86-13482359545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.