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

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.

Study Overview

• Status: Completed
• Conditions: Shock, Septic
• Intervention / Treatment: Biological: Routine biological analyses

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 780

Contacts and Locations

Study Locations

• France
  • Clermont Ferrand, France, 63003
    • CHU de Clermont Ferrand - Hopital Estaing
  • Marseille, France, 13385
    • APHM - Hôpital de la Conception
  • Marseille, France, 13915
    • AP-HM Hôpital Nord
  • Montpellier, France
    • Centre Hospitalier Universitaire de Montpellier
  • Nice, France
    • CHU de Nice
  • Nîmes, France, 30029
    • Centre Hospitalier Universitaire de Nîmes
  • Saint Etienne cedex 2, France, 42055
    • CHU de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Severe septic shock patients entering intensive care units in the participating centers.

Description

Inclusion Criteria:

• patient (or representative) received the information notice
• patient has hemodynamic insufficiency of non-traumatic or cardiogenic origin associated with severe sepsis (treated with Noradrenalin) and organ dysfunction, hypoperfusion or hypotension
• body temperature > 38.3°C or < 36°C
• heart rate > 90 bpm
• Tachypnea > 20 C/min or PaCO2 < 32 mmHg or mechanical ventilation
• leukocytes > 12000 µL-1 ou < 4000 µL-1 ou > 10% immature forms
• oliguria < 0.5 ml/kg/h for at least 2 hours
• abrupt alteration (24 h) of conscienceness
• thrombocytopenia < 100 000 G/L or disseminated intravascular coagulation
• mottled skin and / or capillary refill time> 3 sec
• PaO2/FiO2 < 300 mmHg ou < 40KPas
• Lactatemia > 2mMol/l
• septic shock: Systolic Blood Pressure (SBP) > 90 mmHg or need for vasopressors to maintain SBP> 90 mmHg despite a prior filling (20-30 ml / kg of macromolecules or 40 to 60 ml / kg of normal saline (or decrease in SBP> 40% in the hypertensive)

Exclusion Criteria:

• patient is dying or limitation or cessation of active treatment
• patient is already included in another trial
• patient or family refusal
• patient not affiliated with a social security system

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Septic shock patients	Biological: Routine biological analyses; Bilirubinemia (total and conjugated), hematology, hemogram, SOFA score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Géraldine Lavigne-Lissalde, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: October 29, 2010
• First Submitted That Met QC Criteria: October 29, 2010
• First Posted (Estimate): November 1, 2010

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: PHRC-I/2008/GL-03; 2008-A01214-51 (Other Identifier: RCB number)