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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01686-47 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Harvard Medical School (HMS and HSDM) | OTHER |
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Use Mannose Binding Lectin (MBL) as a biomarker to measure levels of Pathogen- Associated Molecular Patterns (PAMP) during septic shock. This will allow evaluating interest of this biomarker to monitor and manage a septic shock. Consecutive patients admitted for sepsis in Intensive Care Unit Department will be included. This biomarker will be compared to all the parameters monitored usually for these patients in standard care.
Septic shock still represent a major cause of admission in intensive care unit, incidence of severe sepsis is increasing, even in western countries, due to aging populations and comorbidities. Definition of septic shock was revised in 2016 by a task force, which emphasizes the need for future iterations. Indeed, there are no simple clinical or biological criteria ton diagnose septic patients with high risk of shock, or to prognose its severity. C-reactive protein (CRP) and procalcitonin (PCT) are the wider biomarkers used to monitor septic patients. But they do not correlate with sepsis severity and moreover do not distinguish unequivocally between infection and noninfected systemic inflammatory response syndrome (SIRS). Each microorganism has number of PAMPs, cell wall components (lipopolysaccharide endotoxin, peptidoglycan, outer membrane vesicles), flagella, mannan… High levels of these pathogen fragments are released in the bloodstream during sepsis. They trigger release of inflammatory cytokines that drive the sepsis cascade. Mannose binding lectin plays a pivotal role in innate immunity, binding with surface sugars of wide range of pathogens and their fragments. Thus MBL promotes opsonophagocytosis and activates the lectin-complement pathway. Fc-MBL, an engineered version of MBL has been developed to capture microorganism and treat sepsis. An ELISA, using Fc-MBL was developed to measure PAMPs in whole blood during sepsis. This assay will use Fc-MBL ELISA to quantify PAMPs during septic shock, to improve diagnostic and monitoring. But also, identifying patients with high levels of PAMPs for dialysis-like sepsis therapies.
PAMP's level will be compared to clinical, biological, microbiological and therapeutic outcomes. Its sensitivity will be evaluated by its kinetic among a septic shock (defined with Sepsis-3 criteria) and by correlation with CRP (C-Reactive Protein) and PCT (Procalcitonin). Its specificity will be evaluated by comparing its levels during septic and non-septic shocks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with Septic Shock | Experimental | Patient Hospitalized in Intensive Care Unit for sepsis of any etiology. The number of follow-up visits will not be changed compared to usual patient follow-up hospitalized in the intensive care unit but there will be blood testing more frequently |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Test | Biological | Addition to the current care but during the normal follow-up visit :
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| Measure | Description | Time Frame |
|---|---|---|
| Quantify in whole blood presence of PAMP during a septic shock, | Quantify in whole blood presence of PAMP during a septic shock, using Fc-MBL ELISA :t o improve diagnostic by distinguishing a septic shock from another shock, and stating prognosis by studying PAMP kinetic under antibiotherapy. | Follow-up during 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Compare accuracy of Fc-MBL ELISA PAMP assay to CRP and PCT during septic shock. | PAMP's level will be compared to clinical, biological, microbiological and therapeutic outcomes. Its sensitivity will be evaluated by its kinetic among a septic shock (defined with Sepsis-3 criteria) and by correlation with CRP and PCT. Its specificity will be evaluated by comparing its levels during septic and non-septic shocks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Oswald, MD | Contact | 5 67 69 04 17 | 33 | oswald.e@chu-toulouse.fr |
| Isabelle OLIVIER, PhD | Contact | 5 61 77 70 51 | 33 | olivier.i@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Eric Oswald, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Toulouse | Recruiting | Toulouse | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41366523 | Derived | Bicart-See A, Vardon F, Ruiz S, Conil JM, Tudal V, Super M, Ingber DE, Oswald E. Kinetics of molecular patterns captured by mannose-binding lectin in septic shock correlate with clinical outcome: a monocentric prospective observational study. Intensive Care Med Exp. 2025 Dec 10;13(1):123. doi: 10.1186/s40635-025-00832-x. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Major patients admitted to the Resuscitation Department of the CHU Toulouse-Rangueil for severe sepsis, or development of sepsis during the stay resuscitation; sepsis defined by a SOFA score ≥ 2
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| Follow-up during 30 days |
| Study PAMP's kinetic during septic shock from various origins | PAMP's level will be compared to clinical, biological, microbiological and therapeutic outcomes. Its sensitivity will be evaluated by its kinetic among a septic shock (defined with Sepsis-3 criteria) and by correlation with CRP and PCT. Its specificity will be evaluated by comparing its levels during septic and non-septic shocks. | Follow-up during 30 days |
| Identify patients who could beneficiate to a dialysis-like therapy | identifying patients with high levels of PAMPs for dialysis-like sepsis therapies | Follow-up during 30 days |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |