Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital
Paris, 75015, France
NCT Number: NCT02473263
The purpose of this study is to determine whether an aggressive strategy of severe sepsis patients since pre hospital care, including early antibiotics administration, hemodynamic optimization, and opotherapy when indicated, could reduce mortality
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Paris, 75015, France
Major prognostic factor in sepsis management is rapidity of treatments implementation. In 2001, Rivers observed a reduction in mortality through early hemodynamic optimization. In 2009, Arnold emphasizes that establishing more early antibiotic therapy allowed a further reduction of mortality.
In France, pre hospital care is based on mobile intensive care unit (MICU) called SMUR. SMUR is consisting of a driver, a nurse and an emergency physician.
Actually in France, management of severe septic syndrome (severe sepsis and septic shock) are not standardized and based on a "conventional" strategy at the discretion of the emergency physician. Antibiotics are given in only two cases: fulminans purpura and meningitis. Hemodynamic optimization is not a standard of care and no recommendation exist for hemodynamic targets.
An "aggressive" strategy based on early antibiotics administration, hemodynamic optimization and opotherapy when required could be initiated by SMUR since first contact with the patient before hospital admission.
We assume that an "aggressive" strategy initiated during the first 60 minutes of prehospital stage compared to "conventional" strategy could allow to reduce mortality in severe sepsis patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All patients fulfilling the following criteria:
Exclusion criteria
Ceftriaxone 2g IV will be infused in the first 60 minutes, for non nosocomial severe septic syndrome
Piperacillin/tazobactam 4g IV will be infused in the first 60 minutes, for nosocomial severe septic syndrome
Norepinephrine will be infused after failure of hemodynamic optimization using vascular fluid loading
Hydrocortisone 100mg IV will be infused after failure of hemodynamic optimization using norepinephrine with at least 1.5mg/h
Time frame: 28 days
Time frame: 90 days
Time frame: at hospital discharge time, estimated at 90 days
Time frame: at Intensive Care Unit discharge time, estimated at 90 days
Time frame: at hospital discharge time, estimated at 90 days
Time frame: at Intensive Care Unit discharge time, estimated at 90 days
Time frame: at Intensive Care Unit discharge time, estimated at 90 days
Time frame: at Intensive Care Unit discharge time, estimated at 90 days
Assistance Publique - Hôpitaux de Paris
Other
Acronym: SSS
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