Clinical Trial: Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients With Septic Shock

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary:

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.


Detailed Summary:

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: [email protected]


Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome:

  • AUC of the studied prognostic score [ Time Frame: 24 hours (studied score parameters); 1 month (mortality) ]

    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).

  • Negative predictive value of the studied prognostic score [ Time Frame: 24 hours (studied score parameters); 1 month (mortality) ]

    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 (Soci

    Original Primary Outcome: AUC of the 3-marker score [ Time Frame: 1 month ]

    Current Secondary Outcome:

    • AUC of the studied prognostic score [ Time Frame: 24 hours (studied score parameters); 1 week (mortality) ]
      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.
    • Negative predictive value of the studied prognostic score [ Time Frame: 24 hours (studied score parameters); 1 week (mortality) ]
      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.
    • AUC of the studied prognostic score [ Time Frame: 24 hours (studied score parameters); 5 days (DIC) ]

      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).

    • Negative predictive value for the studied prognostic score [ Time Frame: 24 hours (studied score parameters); 5 days (DIC) ]

      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).



    Original Secondary Outcome:

    Information By: Centre Hospitalier Universitaire de Nīmes

    Dates:
    Date Received: October 29, 2010
    Date Started: April 2009
    Date Completion:
    Last Updated: March 26, 2015
    Last Verified: March 2015