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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-A01214-51 | Other Identifier | ANSM |
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A prognostic score was proposed by the investigative team to predict death at 1 month. This score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice management for septic shock.
The main objective of this multicenter study is to validate the performance of the score in terms of area under the ROC curve and negative predictive value.
There are two secondary objectives:
As for the main objective, these scores are based on biological markers scored under emergency situations within the first 24 hours of routine clinical practice management for septic shock.
The objectives and endpoints stated correspond to the protocol directly submitted to ethics authorities prior to the first inclusion and can be verified by contacting the Committee for the Protection of Persons Sud Mediterranée III (mail: CPP SUD-MEDITERRANEE III, UFR MEDECINE 186, chemin du Carreau de Lanes CS 83021, 30908 NIMES Cedex 2 FRANCE. Study reference: 2008.11.04 bis) For more information: carey.suehs@chu-nimes.fr
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Septic shock patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine biological analyses | Biological | Bilirubinemia (total and conjugated), hematology, hemogram, SOFA score |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC of the studied prognostic score | The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death. The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002). | 24 hours (studied score parameters); 1 month (mortality) |
| Negative predictive value of the studied prognostic score | The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death. The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002). | 24 hours (studied score parameters); 1 month (mortality) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of the studied prognostic score | Biological parameters at the time of intensive care unit admission and making up the prognostic score for death at 1 week will be collected. The event "death within 1 week" will be analyzed. For patients discharged from the department before the end of the first week, the clinician will still be informed of possible death. For the prognostic score at 1 week, a single biological parameter is used: fibrinogen. Age and SAPSII are also included in the score. |
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Inclusion Criteria:
Exclusion Criteria:
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Severe septic shock patients entering intensive care units in the participating centers.
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| Name | Affiliation | Role |
|---|---|---|
| Géraldine Lavigne-Lissalde, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont Ferrand - Hôpital Estaing | Clermont-Ferrand | 63003 | France | |||
| APHM - Hôpital de la Conception |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21645228 | Result | Gris JC, Faillie JL, Cochery-Nouvellon E, Lissalde-Lavigne G, Lefrant JY. ISTH overt disseminated intravascular coagulation score in patients with septic shock: automated immunoturbidimetric soluble fibrin assay vs. D-dimer assay. J Thromb Haemost. 2011 Jun;9(6):1252-5. doi: 10.1111/j.1538-7836.2011.04270.x. No abstract available. |
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| 24 hours (studied score parameters); 1 week (mortality) |
| Negative predictive value of the studied prognostic score | Biological parameters at the time of intensive care unit admission and making up the prognostic score for death at 1 week will be collected. The event "death within 1 week" will be analyzed. For patients discharged from the department before the end of the first week, the clinician will still be informed of possible death. For the prognostic score at 1 week, a single biological parameter is used: fibrinogen. Age and SAPSII are also included in the score. | 24 hours (studied score parameters); 1 week (mortality) |
| AUC of the studied prognostic score | Our secondary objective is to validate a clinicobiological score, including hemostasis parameters (clotting factors and coagulation activation) and a clinical score (SOFA) for predicting the occurrence of DIC in the first 5 days after inclusion. The DIC score will be calculated according to ISTH (International Society on Thrombosis and Haemostasis) recommandations (Taylor et al, 2001). | 24 hours (studied score parameters); 5 days (DIC) |
| Negative predictive value for the studied prognostic score | Our secondary objective is to validate a clinicobiological score, including hemostasis parameters (clotting factors and coagulation activation) and a clinical score (SOFA) for predicting the occurrence of DIC in the first 5 days after inclusion. The DIC score will be calculated according to ISTH (International Society on Thrombosis and Haemostasis) recommandations (Taylor et al, 2001). | 24 hours (studied score parameters); 5 days (DIC) |
| Marseille |
| 13385 |
| France |
| AP-HM Hôpital Nord | Marseille | 13915 | France |
| Centre Hospitalier Universitaire de Montpellier | Montpellier | France |
| CHU de Nice | Nice | France |
| Centre Hospitalier Universitaire de Nîmes | Nîmes | 30029 | France |
| CHU de Saint Etienne | Saint-Etienne | 42055 | France |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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