Shock, Septic Clinical Trial
Official title:
Evaluation and Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients Entering Intensive Care Units for Septic Shock
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:
- Validate a prognostic score for death at the end of the first week from initial data.
- Validate a predictive score of disseminated intravascular coagulation (DIC) in patients
with septic shock by comparing with the Gold Standard of the International Society on
Thrombosis and Haemostasis (overt-DIC in the first 5 days after inclusion).
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
;
Observational Model: Cohort, Time Perspective: Prospective
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