Status:
COMPLETED
Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients With Septic Shock
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Shock, Septic
Eligibility:
All Genders
18+ years
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 rou...
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 (DI...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 30 2013
Estimated Enrollment :
780 Patients enrolled
Trial Details
Trial ID
NCT01231672
Start Date
April 1 2009
End Date
October 30 2013
Last Update
November 17 2025
Active Locations (7)
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1
CHU de Clermont Ferrand - Hôpital Estaing
Clermont-Ferrand, France, 63003
2
APHM - Hôpital de la Conception
Marseille, France, 13385
3
AP-HM Hôpital Nord
Marseille, France, 13915
4
Centre Hospitalier Universitaire de Montpellier
Montpellier, France