An observational study in Sepsis and Septic Shock, sponsored by Chang Gung Memorial Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Chang Gung Memorial Hospital · Observational
Early identification and timely intervention for sepsis in the emergency department (ED) are critical for improving patient outcomes. However, clinical diagnosis remains challenging due to the non-specific nature of early systemic symptoms. This study protocol aims to evaluate the diagnostic accuracy of a combined approach using Immature Granulocytes (IG) and Presepsin (sCD14-ST) for the early detection of sepsis in undifferentiated ED patients.
Sepsis is characterized by a dysregulated host inflammatory response to infection, potentially leading to multiple organ dysfunction syndrome (MODS) and death. Globally, the estimated annual incidence of sepsis ranges from 18 to 31.5 million cases, with mortality rates as high as 30%. Approximately 70% of sepsis patients are initially managed in the emergency department (ED). Although delayed recognition and treatment are associated with poorer outcomes, and early evidence-based intervention significantly improves survival , early identification of sepsis in the ED remains a formidable clinical challenge . Despite the critical need for prompt intervention, research indicates that the detection of infection is often delayed by more than 4 hours after hospital admission and by over 8 hours in approximately 30% of ED cases.
Diverse biomarkers have been proposed to facilitate timely diagnosis, risk stratification, and the initiation of appropriate treatment. Complete blood count (CBC) parameters are particularly advantageous in the ED due to their rapid turnaround time, low cost, and repeatability. Traditionally, white blood cell (WBC) count and immature granulocyte (IG) count have served as first-line indicators. Advanced hematology technologies now provide detailed morphologic data (e.g., cell volume and structural changes), potentially enhancing the diagnostic value of these parameters. While IG has been recognized as a marker of systemic inflammation and sepsis, its clinical utility remains a subject of ongoing debate. Specifically, some studies suggest limited predictive value for long-term outcomes such as 28-day mortality, leading to inconsistent conclusions regarding its diagnostic reliability when used in isolation for the detection of sepsis.
Recent investigations into IG for ED sepsis diagnosis have reported areas under the receiver operating characteristic curve (AUC) ranging from 0.52 to 0.93. This pronounced variability is likely attributable to differences in study methodologies and patient populations. Concurrently, Presepsin (soluble CD14 subtype, sCD14-ST) has emerged as a promising alternative biomarker. Presepsin is generated via monocyte activation and pathogen phagocytosis, resulting in a rapid surge in circulating levels during the incipient immune response. Evidence suggests that Presepsin rises earlier than conventional biomarkers and correlates strongly with sepsis severity and clinical outcomes. Specifically, Presepsin has demonstrated superior or comparable diagnostic performance to C-reactive protein (CRP) and procalcitonin (PCT) in emergency settings.
Previous investigations have consistently demonstrated the superior diagnostic performance of Presepsin, with reported Area Under the Receiver Operating Characteristic curve (AUROC) values often exceeding 0.90 in both emergency sepsis presentations and complex postoperative infectious settings, supporting its role as a benchmark biomarker for early infection detection.
In the PRIME-Sepsis Trial (Presepsin and Immature Granulocytes for Multicenter Early Sepsis Detection), we aim to evaluate the synergistic diagnostic accuracy of integrating IG and Presepsin for identifying sepsis in adult patients with a high clinical suspicion of infection in the ED. While Presepsin offers superior diagnostic potential in the hyper-acute phase, IG provides a readily available, cost-effective reflection of the systemic hematopoietic response. By synergizing these complementary biomarkers, our primary objective is to assess the incremental diagnostic yield of a combined molecular-cellular model against multiple reference standards (Sepsis-2, Sepsis-3, and qSOFA). This approach will enable us to derive and evaluate a novel dual-parameter diagnostic algorithm, ultimately facilitating earlier clinical decision-making and improving prognostic accuracy in diverse emergency care settings. This prospective, multicenter design minimizes the biases inherent in previous retrospective analyses, providing a more robust foundation for clinical implementation.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 699 is above the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The study population consists of adult patients (aged 18 years and older) who present to the emergency department of participating multi-center medical institutions with a suspected or confirmed infection and exhibit clinical signs suggestive of early sepsis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical Suspicion of Infection: A high clinical suspicion of infection as determined by the attending emergency physician, accompanied by either a Systemic Inflammatory Response Syndrome (SIRS) score ≥ 2 or a Quick Sequential Organ Failure Assessment (qSOFA) score ≥ 2.
Rationale: This dual-criteria strategy (SIRS or qSOFA) reflects a pragmatic, high-sensitivity approach designed to capture the full spectrum of sepsis in the emergency setting, overcoming the sensitivity limitations of using a single scoring system.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a purely observational study. Peripheral blood samples are collected at enrollment (T0) solely for the laboratory measurement of Presepsin and immature granulocytes (IG). This process does not alter, delay, or interfere with standard clinical diagnosis, management, or treatment decisions in the emergency department.
Diagnostic Accuracy of Presepsin for Early Sepsis Screening
The diagnostic performance of Presepsin (measured in pg/mL) will be evaluated using the Area Under the Receiver Operating Characteristic curve (AUROC). The AUROC will be analyzed to evaluate the ability of Presepsin to differentiate patients with sepsis from those with non-infectious systemic inflammatory response syndrome (SIRS).
Time frame: At enrollment (Time 0 / Emergency Department presentation)
Diagnostic Accuracy of Immature Granulocytes for Early Sepsis Screening
The diagnostic performance of immature granulocytes (IG, measured in percentage) will be evaluated using the Area Under the Receiver Operating Characteristic curve (AUROC). The AUROC will be analyzed to evaluate the ability of IG to differentiate patients with sepsis from those with non-infectious systemic inflammatory response syndrome (SIRS).
Time frame: At enrollment (Time 0 / Emergency Department presentation)
Prognostic Value of Presepsin for Predicting Septic Shock Development
Evaluation of the capability of Presepsin (measured in pg/mL) to predict progression from early sepsis to septic shock. The prognostic performance will be analyzed by calculating the AUROC, sensitivity, specificity, positive predictive value, and negative predictive value.
Time frame: Through 30 days after enrollment
Prognostic Value of Immature Granulocytes for Predicting Septic Shock Development
Evaluation of the capability of immature granulocytes (IG, measured in percentage) to predict progression from early sepsis to septic shock. The prognostic performance will be analyzed by calculating the AUROC, sensitivity, specificity, positive predictive value, and negative predictive value.
Time frame: Through 30 days after enrollment
Concentration of Presepsin for Predicting 30-Day All-Cause Mortality
Concentration of Presepsin (measured in pg/mL) used to assess the 30-day all-cause mortality rate post-enrollment. The prognostic performance will be evaluated by calculating the Area Under the Receiver Operating Characteristic curve (AUROC) and the Odds Ratio (OR) derived from multiple logistic regression analysis to determine the predictive capability of Presepsin for 30-day mortality.
Time frame: 30 days post-enrollment
Percentage of Immature Granulocytes for Predicting 30-Day All-Cause Mortality
Percentage of immature granulocytes (measured in percentage, %) used to assess the 30-day all-cause mortality rate post-enrollment. The prognostic performance will be evaluated by calculating the Area Under the Receiver Operating Characteristic curve (AUROC) and the Odds Ratio (OR) derived from multiple logistic regression analysis to determine the predictive capability of immature granulocytes for 30-day mortality.
Time frame: 30 days post-enrollment
Plan to share: Undecided
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.
Of 189 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 24 months is close to that.
Counting every sponsor, half of 202 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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