Severe Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit
Conditions
Keywords
Severe septic syndrome, mobile intensive care unit, strategy, antibiotics, hemodynamic optimization
Brief summary
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
Detailed description
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.
Interventions
DRUGCeftriaxone
Ceftriaxone 2g IV will be infused in the first 60 minutes, for non nosocomial severe septic syndrome
DRUGPiperacillin tazobactam
Piperacillin/tazobactam 4g IV will be infused in the first 60 minutes, for nosocomial severe septic syndrome
DRUGNorepinephrine
Norepinephrine will be infused after failure of hemodynamic optimization using vascular fluid loading
DRUGHydrocortisone
Hydrocortisone 100mg IV will be infused after failure of hemodynamic optimization using norepinephrine with at least 1.5mg/h
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients fulfilling the following criteria: * Age ≥ 18 years * Patient with suspected severe infection defined by the existence of a suspected infection AND * Hypotension before vascular fluid loading AND/OR * Lactataemia greater than 4 mmol/l AND/OR * Glasgow scale lower than 13 AND/OR * Mottling score greater than 2 * Patient with a septic shock
Exclusion criteria
* Age \<18 years or Unable * Pregnant * Severe concomitant pathology requiring urgent care(i.e.epilepsy) * Status "not to be reanimated" life expectancy less than 6 months with no indication of reanimation support ( prior decision on care limitation). * Fulminans purpura * True allergy to beta-lactam defined by an angioedema or by an anaphylactic shock during a prior exposure to beta-lactam. * Patient who have already received hemodynamic optimization or antibiotic treatment before the MICU's (Mobile Intensive Care Unit) care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of death | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of death | 90 days |
| Number of days of stay in intensive care unit | at Intensive Care Unit discharge time, estimated at 90 days |
| Number of days of stay at hospital | at hospital discharge time, estimated at 90 days |
| Number of days of vasopressor support | at Intensive Care Unit discharge time, estimated at 90 days |
| Number of days of mechanical ventilation support | at Intensive Care Unit discharge time, estimated at 90 days |
| Number of days of renal replacement therapy | at Intensive Care Unit discharge time, estimated at 90 days |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORRomain Jouffroy, MD
Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital - 149 rue de Sèvres 75015 Paris - France
Outcome results
None listed