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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01231672
First received: October 29, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Shock, Septic
Biological: Routine biological analyses

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • AUC of the studied prognostic score [ Time Frame: 24 hours (studied score parameters); 1 month (mortality) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • AUC of the studied prognostic score [ Time Frame: 24 hours (studied score parameters); 1 week (mortality) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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).



Enrollment: 780
Study Start Date: April 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Septic shock patients Biological: Routine biological analyses
Bilirubinemia (total and conjugated), hematology, hemogram, SOFA score

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231672

Locations
France
CHU de Clermont Ferrand - Hôpital Estaing
Clermont Ferrand, France, 63003
AP-HM Hôpital Nord
Marseille, France, 13915
APHM - Hôpital de la Conception
Marseille, France, 13385
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
CHU de Nice
Nice, France
Centre Hospitalier Universitaire de Nîmes
Nîmes, France, 30029
CHU de Saint Etienne
Saint Etienne cedex 2, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Géraldine Lavigne-Lissalde, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01231672     History of Changes
Other Study ID Numbers: PHRC-I/2008/GL-03, 2008-A01214-51
Study First Received: October 29, 2010
Last Updated: March 3, 2014
Health Authority: France: Committee for the Protection of Personnes
France: The Commission nationale de l’informatique et des libertés

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on September 18, 2014