About this trial
This prospective, multicenter, observational cohort study enrolls 6,000 adults with sepsis and/or acute respiratory distress syndrome (ARDS) at multiple hospitals in China. Clinical data, treatment information, biological samples, and follow-up data are collected to characterize patient features and outcomes and to establish a multicenter clinical cohort and biobank.
The study focuses on the clinical and biological heterogeneity of sepsis and ARDS. Longitudinal clinical data are integrated with information on organ function, inflammatory and immune responses, and multi-omics profiles to identify clinically relevant phenotypes and biological subgroups. Biomarkers associated with disease severity, organ dysfunction, treatment response, and mortality are explored, together with models for outcome prediction. Follow-up after hospitalization evaluates long-term survival and recovery, including pulmonary function, physical function, quality of life, and psychological health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Admitted to an ICU or other designated inpatient unit at a participating study center, including emergency or respiratory care units where appropriate.
Written informed consent is obtained from the participant or a legally authorized representative, or deferred consent is used when permitted by local ethical requirements.
Disqualifiers
The acute clinical condition is primarily explained by an alternative diagnosis without sepsis or ARDS, such as isolated cardiogenic pulmonary edema or fluid overload without ARDS.
Terminal illness with an expected survival of <24 hours, or a decision for comfort measures only has been made before enrollment.
Informed consent cannot be obtained in accordance with applicable ethical requirements.
Previous enrollment in this cohort. Each participant may be enrolled only once; subsequent episodes of sepsis and/or ARDS may be recorded as clinical events but will not result in repeated enrollment.
Trial population
A total of 6,000 adult patients with sepsis and/or acute respiratory distress syndrome (ARDS) will be enrolled across multiple medical centers in China. The cohort will include hospitalized adults who meet the study diagnostic criteria for sepsis and/or ARDS. Clinical data and biological samples will be collected during hospitalization to characterize the clinical and biological features of sepsis and ARDS. Biological samples will support biomarker and multi-omics analyses, and survivors with ARDS will be followed after hospital discharge to assess long-term survival, pulmonary and physical function, quality of life, psychological health, and rehospitalization.
Trial design
Cohort
Prospective
Treatments tested in this trial
Surveys
Other interventionParticipants will complete the EuroQol-5 Dimension-5 Level (EQ-5D-5L) quality of life assessment in person. Assessments will be conducted at 1, 6, 12, and 24 month(s) following hospitalization. For participants who do not attend in-person follow-up visits, surveys will be conducted via email, text message, or phone.
6-Minute Walk Test
Other interventionThe patient sits at rest while baseline vital signs and exertion scores are taken.The patient then walks back and forth along a flat, marked corridor at their own pace for 6 minutes, followed immediately by repeating vital signs and exertion measurements at the finish. At visits 1, 6, 12 and 24 month(s) following hospitalization.
Blood collection
Other interventionVenous blood is collected via direct needle stick into a vein. Arterial blood is collected by a direct needle puncture into an artery (typically the radial artery) using a heparinized syringe. At visits 1, 6, 12 and 24 month(s) following hospitalization.
Pulmonary & Respiratory Muscle Function Testing
Diagnostic testThe patient sits upright, wears a nose clip, and breathes through a mouthpiece connected to the testing device, performing guided forced breathing and single-breath hold maneuvers. Respiratory muscle strength is measured by having the patient inhale and exhale forcefully against a temporarily blocked mouthpiece. At visits 1, 6, 12 and 24 month(s) following hospitalization.
CT Scan
RadiationThe patient lies flat on the CT scanner bed and follows automated breathing prompts to hold their breath for a few seconds while images are acquired. Additional body regions may be scanned if clinically indicated. At visits 1, 6, 12 and 24 month(s) following hospitalization.
Blood Collection
Other interventionBlood samples will be collected on Day 1, Day 3, and Day 7. Day 1 samples will be collected within 48 hours after ARDS diagnosis. Day 7 samples can be collected between Day 6 and Day 8. Plasma、 PBMCs and Serum will be collected in each corresponding tube and will be separated and stored for later testing. Citrate plasma will be collected in sodium citrate tubes and then will be centrifuged within 1 hour, and the plasma will be stored at -80°C for later testing.
Bronchoalveolar Lavage Fluid
Other interventionBronchoalveolar lavage fluid (BALF) will be collected on Day 1, Day 3, and Day 7 and stored for later testing.
HME filter samples
Other interventionHME filter samples will be collected on Day 1, Day 3, and Day 7 and stored for later testing. If the patient is extubated, dies, or leaves the hospital before the planned BALF or HME sample collection, the last sample will be collected before or on the same day.
Treatment groups
Trial outcomes
Primary outcomes
All cause mortality
EuroQol-5 Dimension-5 Level (EQ-5D-5L) quality of life assessment
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, participants select one of five response levels, ranging from no problems to extreme problems or inability to perform the activity; the distribution of response levels within each dimension will be summarized as percentages. Responses across the five dimensions will also be converted to an EQ-5D-5L index score using a prespecified value set, with higher index scores indicating better health-related quality of life. Participants will additionally rate their overall health using the EQ Visual Analogue Scale (EQ VAS), ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Secondary outcomes
60-day all-cause mortality
Death from any cause within 60 days after ARDS diagnosis
90-day all-cause mortality
Death from any cause within 90 days after ARDS diagnosis
ICU mortality
Death occurring during the ICU stay
In-hospital mortality
Death occurring during the index hospitalization
Other outcomes
Ventilator-Free Days (VFD)
Extracorporeal Membrane Oxygenation-Free Days (ECMO-free days)
Renal Replacement Therapy-Free Days
Lymphocyte Subsets （CD19+ B, CD3+ T, CD4+ Th, CD8+ Ts, CD4/CD8, CD16+CD56+ NK）
Sponsors and contacts
Click on the lead sponsor to view all of their trials.