A Real World Study of Respiratory Critical Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention: Observational Cohort.
- Who it may be relevant to
- Registry conditions: ARDS (Acute Respiratory Distress Syndrome), Real World Study. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other No Intervention: Observational Cohort
Obsercational study
Primary outcome measures
- Mortality [Time frame: Day 28 after ARDS diagnosis]
- Mortality [Time frame: Day 60 after ARDS diagnosis]
Secondary outcome measures (5)
- Chest CT Scan [Time frame: Monitored daily]
- Complete Blood Count [Time frame: Monitored daily]
- Serial Arterial Blood Gas Monitoring [Time frame: Monitored daily after enrollment]
- Fluid Input and Output Balance [Time frame: Whenever fluid input or output occurs]
- Mechanical Ventilation Monitoring [Time frame: Every second after intubation]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fudan University, Zhong Shan Hospital — Shanghai
Identifiers
NCT: NCT07165717 · B2023-016