Trial · NCT07896018
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
NCT07896018, Recruiting, Sir Run Run Shaw Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study. Trials, record NCT07896018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07896018
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
- NCT number
- NCT07896018
- Status
- Recruiting
- Enrollment
- 3,000 participants, estimated
- Lead sponsor
- Sir Run Run Shaw Hospital
- Conditions
- Sepsis
- First posted
- 2026-10-26
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Diagnostic Accuracy of Neutrophil EMR3 Expression for Sepsis | At baseline (T0), within 6 hours of enrollment or initial ICU admission. | The diagnostic accuracy of baseline neutrophil EMR3 expression for identifying sepsis will be evaluated using the area under the receiver operating characteristic curve (ROC-AUC), with a 95% confidence interval. EMR3 expression will be measured by flow cytometry using residual EDTA-anticoagulated whole blood. The primary comparison will be between patients with sepsis or septic shock and patients with infection without sepsis or noninfectious critical illness. Healthy or elective surgical controls will be excluded from the primary diagnostic comparison. |
| Secondary | Changes in Neutrophil EMR3 Expression Over Time | Baseline (T0), 72 ± 12 hours (T1), Day 7 ± 1 day (T2), and optionally Day 14 ± 2 days (T3). | Longitudinal changes in neutrophil EMR3 expression, measured by flow cytometry, will be evaluated in patients with sepsis or septic shock. Changes in EMR3 expression will be analyzed in relation to disease severity, organ dysfunction, and established inflammatory biomarkers. |
| Secondary | All-Cause Mortality at 28 Days | From enrollment through Day 28. | The proportion of patients with sepsis or septic shock who die from any cause within 28 days after enrollment. Associations between baseline EMR3 expression, longitudinal EMR3 changes, and mortality will be evaluated. |
| Secondary | Diagnostic Accuracy of EMR3 for Septic Shock | At baseline (T0), within 6 hours of enrollment or initial ICU admission. | The ability of baseline neutrophil EMR3 expression to identify septic shock will be assessed using receiver operating characteristic curve analysis, including the area under the curve (AUC), sensitivity, and specificity. Septic shock will be defined according to Sepsis-3 criteria. |
| Secondary | Association Between EMR3 Expression and Organ Dysfunction | Baseline, 72 ± 12 hours, and Day 7 ± 1 day; optionally Day 14 ± 2 days. | The association between neutrophil EMR3 expression and organ dysfunction will be evaluated using Sequential Organ Failure Assessment (SOFA) scores. Longitudinal changes in EMR3 expression will be compared with changes in SOFA scores to assess their relationship with disease progression and recovery. |
| Secondary | Incidence of Secondary Infections | From enrollment through Day 28. | The proportion of patients with sepsis or septic shock who develop secondary infections during hospitalization. The association between neutrophil EMR3 expression and the occurrence of secondary infections will be evaluated. |
| Secondary | Intensive Care Unit Length of Stay | From ICU admission to ICU discharge, assessed through Day 28. | Duration of intensive care unit hospitalization, measured in days. The association between baseline EMR3 expression, longitudinal EMR3 changes, and ICU length of stay will be assessed. |
| Secondary | Duration of Organ Support | From enrollment through Day 28. | Duration of organ support, including invasive mechanical ventilation, vasopressor therapy, and continuous renal replacement therapy, measured in days. Associations between EMR3 expression and organ support requirements will be evaluated. |
| Secondary | Incremental Predictive Value of EMR3 in Combined Models | Baseline through Day 28. | The incremental diagnostic and prognostic value of adding EMR3 to models containing established clinical biomarkers and severity scores will be evaluated. Model performance will be compared using the area under the receiver operating characteristic curve (AUC), calibration, net reclassification improvement (NRI), and integrated discrimination improvement (IDI). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07896018
GET https://conductscience.org/api/trials/v1/NCT07896018/registered