Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock
- Conditions
- Severe Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit
- Interventions
- Registration Number
- NCT02473263
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 398
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aggressive Piperacillin tazobactam Antibiotics (Ceftriaxone or piperacillin tazobactam) administration, hemodynamic optimization and opotherapy (norepinephrine, hydrocortisone) when required should be performed in the first 60 minutes after contact with the patient Aggressive Ceftriaxone Antibiotics (Ceftriaxone or piperacillin tazobactam) administration, hemodynamic optimization and opotherapy (norepinephrine, hydrocortisone) when required should be performed in the first 60 minutes after contact with the patient Aggressive Norepinephrine Antibiotics (Ceftriaxone or piperacillin tazobactam) administration, hemodynamic optimization and opotherapy (norepinephrine, hydrocortisone) when required should be performed in the first 60 minutes after contact with the patient Aggressive Hydrocortisone Antibiotics (Ceftriaxone or piperacillin tazobactam) administration, hemodynamic optimization and opotherapy (norepinephrine, hydrocortisone) when required should be performed in the first 60 minutes after contact with the patient
- Primary Outcome Measures
Name Time Method Number of death 28 days
- Secondary Outcome Measures
Name Time Method Number of days of mechanical ventilation support at Intensive Care Unit discharge time, estimated at 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 vasopressor 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 Number of death at hospital discharge time, estimated at 90 days Number of days of stay at hospital at hospital discharge time, estimated at 90 days
Trial Locations
- Locations (1)
Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital
🇫🇷Paris, France