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

NCT01231672 | Completed

• 2 other identifiers: PHRC-I/2008/GL-032008-A01214-51
• Study Type: observational
• Target: 780
• Locations: 1 country
• Sites: 7

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.

Conditions

Shock, Septic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• AUC of the studied prognostic score

  24 hours (studied score parameters); 1 week (mortality)

• Negative predictive value of the studied prognostic score

  24 hours (studied score parameters); 1 week (mortality)

• AUC of the studied prognostic score

  24 hours (studied score parameters); 5 days (DIC)

• Negative predictive value for the studied prognostic score

  24 hours (studied score parameters); 5 days (DIC)

Study Arms (1)

Septic shock patients

Biological: Routine biological analyses

Interventions

Routine biological analyses BIOLOGICAL

Bilirubinemia (total and conjugated), hematology, hemogram, SOFA score

Septic shock patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (7)

CHU de Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, 63003, France

Location

APHM - Hôpital de la Conception

Marseille, 13385, France

Location

AP-HM Hôpital Nord

Marseille, 13915, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Location

CHU de Nice

Nice, France

Location

Centre Hospitalier Universitaire de Nîmes

Nîmes, 30029, France

Location

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

• 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.

  PMID: 21645228 RESULT

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Géraldine Lavigne-Lissalde, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 1, 2010
• Study Start: April 1, 2009
• Primary Completion: October 30, 2013
• Study Completion: October 30, 2013
• Last Updated: November 17, 2025

Record last verified: 2015-03

Locations

FR (7)