Crick
HomeTrialsGenesDrugs23andMeGraphBlogContact
  • Home
  • Trials
  • Genes
  • Drugs
  • 23andMe
  • Graph
  • Blog
  • Contact
Crick

An open-source clinical intelligence platform. Explore clinical trials, gene networks, and molecular structures using public data sources.

Data Sources

  • ClinicalTrials.gov
  • OpenTargets
  • ClinVar
  • PubChem

Links

  • Contact
  • About
  • Privacy

© 2026 Crick. All rights reserved.

Crick is for educational purposes only. Not medical advice.

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

Phase 3CompletedNCT02473263
Assistance Publique - Hôpitaux de Paris398 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

398

Conditions

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

Interventions

CeftriaxoneDRUG

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

Piperacillin tazobactamDRUG

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

NorepinephrineDRUG

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

HydrocortisoneDRUG

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

Eligibility

Sex: ALLMin age: 18 Years
Medical Language ↔ Plain English
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.

Locations (1)

Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital

Paris, France

Outcomes

Primary Outcomes

Number of death

Time frame: 28 days

Secondary Outcomes

Number of death

Time frame: 90 days

Number of death

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

Number of days of stay in intensive care unit

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

Number of days of stay at hospital

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

Number of days of vasopressor support

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

Number of days of mechanical ventilation support

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

Number of days of renal replacement therapy

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.