SepsisNCT07913464
PF-Organized Corticosteroid-Associated Heterogeneity in Sepsis
An observational study of Sepsis and Critical Illness, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This retrospective multicohort observational study evaluates whether the PaO2/FiO2 ratio (P/F ratio) organizes heterogeneity in the association between early systemic corticosteroid exposure and mortality among critically ill patients with sepsis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis, Critical Illness
- What is being tested?
- Systemic Corticosteroids
- How many people
- 2,693 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2026to 27 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of critically ill patients with sepsis identified from three ICU databases: the internal ICCA cohort and the external MIMIC and eICU cohorts. The ICCA cohort included ICU stays meeting the finalized sepsis phenotype based on organ dysfunction and infection-related evidence. MIMIC and eICU cohorts were used for broad external testing and subsequently reconstructed toward vasopressor-anchored shock-decision contexts. All data were obtained retrospectively from routinely collected clinical records or existing critical-care databases, and treatment was not assigned by the investigators.
Who may be able to join
- ICU stays or eligible ICU records from the ICCA, MIMIC, or eICU databases.
- Meets the database-specific operational definition of sepsis used in the study.
- Has an ascertainable ICU mortality outcome or the corresponding harmonized database-specific mortality endpoint.
- Has the relevant corticosteroid exposure and clinical data required for the corresponding analysis.
Who cannot join
- ICU stays or records that do not meet the finalized database-specific sepsis definition.
- For the ICCA cohort, ICU stays with a duration of 48 hours or less.
- For the ICCA cohort, records with antimicrobial treatment patterns more consistent with postoperative prophylaxis than active infection.
- Records with unavailable or invalid mortality outcome information.
- Records with missing exposure or other essential variables required for the corresponding analysis.
- Analysis-specific exclusions:
- Records without available PaO₂/FiO₂ measurements were excluded from analyses requiring P/F stratification, but were not necessarily excluded from the broader source cohort.
- Records with missing model-specific covariates were excluded from the corresponding complete-case analyses only.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Decision-Context-Aligned Multicohort Framework for PF-Organized Corticosteroid-Associated Heterogeneity in Sepsis
This retrospective multicohort observational study evaluates whether the PaO2/FiO2 ratio (P/F ratio) organizes heterogeneity in the association between early systemic corticosteroid exposure and mortality among critically ill patients with sepsis.
The study uses one internal critical-care cohort (ICCA) and two external critical-care databases (MIMIC and eICU). Analyses include internal discovery, broad external testing, reconstruction of external cohorts toward vasopressor-anchored shock-decision contexts, realized-exposure observational analyses, and strategy-level analyses using a simplified clone-censor-weighting framework (Lite-CCW).
The primary objective is to characterize whether corticosteroid-associated outcome patterns differ across P/F strata and whether similar directional patterns are observed across independent ICU datasets after decision-context reconstruction. The study is hypothesis-generating and does not assign corticosteroid treatment or define a clinical treatment-selection rule.
- Conditions
- Sepsis, Critical Illness
- Being tested
- Systemic Corticosteroids
- Keywords
- Corticosteroids, P/F ratio, Septic shock
- Medical subject headings
- Sepsis, Critical Illness, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic CorticosteroidsDrug
Systemic corticosteroid exposure occurring as part of routine clinical care. Treatment was not assigned by the investigators. For realized-exposure observational analyses, corticosteroid exposure was defined within 0-72 hours after time zero in the ICCA cohort and within 0-24 hours in the MIMIC and eICU cohorts. Strategy-level analyses evaluated corticosteroid initiation within 24 hours versus no initiation during the corresponding 24-hour strategy window.
| Study group | Role | What they receive |
|---|---|---|
| ICCA Cohort | Critically ill patients meeting the finalized ICCA sepsis phenotype. Realized systemic corticosteroid exposure was assessed within 0-72 hours after cohort time zero. The finalized manuscript-facing ICCA cohort included 2,693 ICU stays. Receives: Drug: Systemic Corticosteroids | |
| MIMIC Cohort | Patients represented in the broad MIMIC ICU cohort, with reconstructed main and shock-aligned subsets used for external decision-context analyses. Realized corticosteroid exposure was assessed within 0-24 hours after time zero. Receives: Drug: Systemic Corticosteroids | |
| eICU Cohort | Patients represented in the broad eICU critical-care cohort, with reconstructed main and shock-aligned subsets used for external decision-context analyses. Realized corticosteroid exposure was assessed within 0-24 hours after time zero. Receives: Drug: Systemic Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
Death during the index ICU stay, based on the ICU mortality variable recorded in each database.
Measured: From ICU admission (cohort entry) until ICU discharge or death, whichever occurred first, during the index ICU stay. The maximum observed follow-up duration was 90 days.
Secondary outcomes (3)
ICU Mortality by PaO2/FiO2 (P/F) Stratum
ICU mortality evaluated separately in patients with baseline PaO₂/FiO₂ ≤200 mmHg and >200 mmHg.
Measured: From ICU admission (cohort entry) until ICU discharge or death, whichever occurred first, during the index ICU stay. The maximum observed follow-up duration was 90 days.
Strategy-Level Association Between Early Corticosteroid Initiation and ICU Mortality
Comparison of ICU mortality between an early corticosteroid initiation strategy (within 24 hours after cohort entry) and a no-early-initiation strategy during the same 24-hour window, using the limited clone-censor-weighting framework.
Measured: From cohort entry (ICU admission) until ICU discharge or death, whichever occurred first, during the index ICU stay. The treatment-strategy assignment window was the first 24 hours after cohort entry. The maximum observed follow-up duration was 90 days.
P/F-Stratified Associations Between Corticosteroid Exposure and ICU Mortality Across Cohorts
Adjusted odds ratios (ORs) with 95% confidence intervals (CIs) for the association between systemic corticosteroid exposure and ICU mortality were compared across ICCA, MIMIC, and eICU cohorts within P/F ≤200 mmHg and P/F >200 mmHg strata. Exposure windows followed source-specific definitions (0-72 hours in ICCA and within 24 hours in MIMIC and eICU). Broad and reconstructed external cohorts were evaluated separately. These exploratory comparisons did not constitute formal tests of cross-cohort replication, transportability, or causal effects.
Measured: From ICU admission or cohort entry (time zero) until ICU discharge or death, whichever occurred first, during the index ICU stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start5 Aug 2026
- Primary completion25 Sep 2026
- Study completion27 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913464
- Sponsor's protocol ID
- 20260803
- Status last verified
- Nov 2026
- First submitted
- 4 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decision-Context-Aligned Multicohort Framework for PF-Organized Corticosteroid-Associated Heterogeneity in Sepsis
- ClinicalTrials.gov ID
- NCT07913464
- Acronym / sponsor ID
- 20260803
- Conditions
- Sepsis, Critical Illness
- Keywords
- Corticosteroids, P/F ratio, Septic shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,693 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 27 Sep 2026 (actual)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective multicohort observational study evaluates whether the PaO2/FiO2 ratio (P/F ratio) organizes heterogeneity in the association between early systemic corticosteroid exposure and mortality among critically ill patients with sepsis.
The study uses one internal critical-care cohort (ICCA) and two external critical-care databases (MIMIC and eICU). Analyses include internal discovery, broad external testing, reconstruction of external cohorts toward vasopressor-anchored shock-decision contexts, realized-exposure observational analyses, and strategy-level analyses using a simplified clone-censor-weighting framework (Lite-CCW).
The primary objective is to characterize whether corticosteroid-associated outcome patterns differ across P/F strata and whether similar directional patterns are observed across independent ICU datasets after decision-context reconstruction. The study is hypothesis-generating and does not assign corticosteroid treatment or define a clinical treatment-selection rule.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICCA Cohort | – | Drug: Systemic CorticosteroidsCritically ill patients meeting the finalized ICCA sepsis phenotype. Realized systemic corticosteroid exposure was assessed within 0-72 hours after cohort time zero. The finalized manuscript-facing ICCA cohort included 2,693 ICU stays. |
| MIMIC Cohort | – | Drug: Systemic CorticosteroidsPatients represented in the broad MIMIC ICU cohort, with reconstructed main and shock-aligned subsets used for external decision-context analyses. Realized corticosteroid exposure was assessed within 0-24 hours after time zero. |
| eICU Cohort | – | Drug: Systemic CorticosteroidsPatients represented in the broad eICU critical-care cohort, with reconstructed main and shock-aligned subsets used for external decision-context analyses. Realized corticosteroid exposure was assessed within 0-24 hours after time zero. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of critically ill patients with sepsis identified from three ICU databases: the internal ICCA cohort and the external MIMIC and eICU cohorts. The ICCA cohort included ICU stays meeting the finalized sepsis phenotype based on organ dysfunction and infection-related evidence. MIMIC and eICU cohorts were used for broad external testing and subsequently reconstructed toward vasopressor-anchored shock-decision contexts. All data were obtained retrospectively from routinely collected clinical records or existing critical-care databases, and treatment was not assigned by the investigators.
Key inclusion criteria (4 listed)
- ICU stays or eligible ICU records from the ICCA, MIMIC, or eICU databases.
- Meets the database-specific operational definition of sepsis used in the study.
- Has an ascertainable ICU mortality outcome or the corresponding harmonized database-specific mortality endpoint.
- Has the relevant corticosteroid exposure and clinical data required for the corresponding analysis.
Key exclusion criteria (8 listed)
- ICU stays or records that do not meet the finalized database-specific sepsis definition.
- For the ICCA cohort, ICU stays with a duration of 48 hours or less.
- For the ICCA cohort, records with antimicrobial treatment patterns more consistent with postoperative prophylaxis than active infection.
- Records with unavailable or invalid mortality outcome information.
- Records with missing exposure or other essential variables required for the corresponding analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic CorticosteroidsSystemic corticosteroid exposure occurring as part of routine clinical care. Treatment was not assigned by the investigators. For realized-exposure observational analyses, corticosteroid exposure was defined within 0-72 hours after time zero in the ICCA cohort and within 0-24 hours in the MIMIC and eICU cohorts. Strategy-level analyses evaluated corticosteroid initiation within 24 hours versus no initiation during the corresponding 24-hour strategy window. | Drug | ICCA Cohort, MIMIC Cohort, eICU Cohort |
Primary outcome
ICU Mortality
Time frame: From ICU admission (cohort entry) until ICU discharge or death, whichever occurred first, during the index ICU stay. The maximum observed follow-up duration was 90 days.
Death during the index ICU stay, based on the ICU mortality variable recorded in each database.
3 secondary outcomes
ICU Mortality by PaO2/FiO2 (P/F) Stratum
Time frame: From ICU admission (cohort entry) until ICU discharge or death, whichever occurred first, during the index ICU stay. The maximum observed follow-up duration was 90 days.
Strategy-Level Association Between Early Corticosteroid Initiation and ICU Mortality
Time frame: From cohort entry (ICU admission) until ICU discharge or death, whichever occurred first, during the index ICU stay. The treatment-strategy assignment window was the first 24 hours after cohort entry. The maximum observed follow-up duration was 90 days.
P/F-Stratified Associations Between Corticosteroid Exposure and ICU Mortality Across Cohorts
Time frame: From ICU admission or cohort entry (time zero) until ICU discharge or death, whichever occurred first, during the index ICU stay.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Critical Illness, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Mortality (time frame: From ICU admission (cohort entry) until ICU discharge or death, whichever occurred first, during the index ICU stay. The maximum observed follow-up duration was 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.