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Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock (SSS)

A

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed
Phase 3

Conditions

Severe Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit

Treatments

Drug: Ceftriaxone
Drug: Norepinephrine
Drug: Hydrocortisone
Drug: Piperacillin tazobactam

Study type

Interventional

Funder types

Other

Identifiers

NCT02473263
2014-A01030-47

Details and patient eligibility

About

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

Full 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.

Enrollment

398 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

398 participants in 2 patient groups

Conventional
No Intervention group
Description:
No antibiotic administration and no hemodynamic target are required
Aggressive
Active Comparator group
Description:
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
Treatment:
Drug: Hydrocortisone
Drug: Piperacillin tazobactam
Drug: Ceftriaxone
Drug: Norepinephrine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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