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

NCT02473263 | Completed Phase 3 DMC

• 1 other identifier: 2014-A01030-47
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Severe septic syndrome; mobile intensive care unit; strategy; antibiotics; hemodynamic optimization

Outcome Measures

Primary Outcomes (1)

• Number of death

  28 days

Secondary Outcomes (7)

• Number of death

  90 days

• Number of death

  at hospital 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 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

Study Arms (2)

Conventional

NO INTERVENTION

No antibiotic administration and no hemodynamic target are required

Aggressive

ACTIVE COMPARATOR

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

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

Interventions

Ceftriaxone DRUG

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

Aggressive

Piperacillin tazobactam DRUG

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

Aggressive

Norepinephrine DRUG

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

Aggressive

Hydrocortisone DRUG

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

Aggressive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital

Paris, 75015, France

Location

Related Publications (5)

• Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

  PMID: 11794169 BACKGROUND

• Pottecher T, Calvat S, Dupont H, Durand-Gasselin J, Gerbeaux P; SFAR/SRLF workgroup. Haemodynamic management of severe sepsis: recommendations of the French Intensive Care Societies (SFAR/SRLF) Consensus Conference, 13 October 2005, Paris, France. Crit Care. 2006;10(4):311. doi: 10.1186/cc4965.

  PMID: 16941754 BACKGROUND

• Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96. doi: 10.1097/01.CCM.0000217961.75225.E9.

  PMID: 16625125 BACKGROUND

• Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Intensive Care Med. 2008 Jan;34(1):17-60. doi: 10.1007/s00134-007-0934-2. Epub 2007 Dec 4.

  PMID: 18058085 BACKGROUND

• Sebat F, Johnson D, Musthafa AA, Watnik M, Moore S, Henry K, Saari M. A multidisciplinary community hospital program for early and rapid resuscitation of shock in nontrauma patients. Chest. 2005 May;127(5):1729-43. doi: 10.1378/chest.127.5.1729.

  PMID: 15888853 BACKGROUND

MeSH Terms

Conditions

Toxemia; Sepsis; Shock, Septic; Disease

Interventions

Ceftriaxone; Piperacillin, Tazobactam Drug Combination; Norepinephrine; Hydrocortisone

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tazobactam; Penicillanic Acid; Penicillins; Piperacillin; Ampicillin; Penicillin G; Sulfones; Drug Combinations; Pharmaceutical Preparations; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Romain Jouffroy, MD

  Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital - 149 rue de Sèvres 75015 Paris - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 16, 2015
• Study Start: May 9, 2016
• Primary Completion: February 9, 2019
• Study Completion: February 9, 2019
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)