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Completed

NCT Number: NCT02473263

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ceftriaxone

Drug

Ceftriaxone 2g IV will be infused in the first 60 minutes, for non nosocomial severe septic syndrome

Piperacillin tazobactam

Drug

Piperacillin/tazobactam 4g IV will be infused in the first 60 minutes, for nosocomial severe septic syndrome

norepinephrine

Drug

Norepinephrine will be infused after failure of hemodynamic optimization using vascular fluid loading

Hydrocortisone

Drug

Hydrocortisone 100mg IV will be infused after failure of hemodynamic optimization using norepinephrine with at least 1.5mg/h

Primary outcomes

  1. Number of death

    Time frame: 28 days

Secondary outcomes

  1. Number of death

    Time frame: 90 days

  2. Number of death

    Time frame: at hospital discharge time, estimated at 90 days

  3. Number of days of stay in intensive care unit

    Time frame: at Intensive Care Unit discharge time, estimated at 90 days

  4. Number of days of stay at hospital

    Time frame: at hospital discharge time, estimated at 90 days

  5. Number of days of vasopressor support

    Time frame: at Intensive Care Unit discharge time, estimated at 90 days

  6. Number of days of mechanical ventilation support

    Time frame: at Intensive Care Unit discharge time, estimated at 90 days

  7. Number of days of renal replacement therapy

    Time frame: at Intensive Care Unit discharge time, estimated at 90 days

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: SSS

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 16, 2015
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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