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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 9, 2019

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.

Interventions

  • Drug: Ceftriaxone
    • Ceftriaxone 2g IV will be infused in the first 60 minutes, for non nosocomial severe septic syndrome
  • Drug: Piperacillin tazobactam
    • Piperacillin/tazobactam 4g IV will be infused in the first 60 minutes, for nosocomial severe septic syndrome
  • Drug: Norepinephrine
    • Norepinephrine will be infused after failure of hemodynamic optimization using vascular fluid loading
  • Drug: Hydrocortisone
    • Hydrocortisone 100mg IV will be infused after failure of hemodynamic optimization using norepinephrine with at least 1.5mg/h

Arms, Groups and Cohorts

  • No Intervention: Conventional
    • No antibiotic administration and no hemodynamic target are required
  • Active Comparator: Aggressive
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Number of death
    • Time Frame: 28 days

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Romain Jouffroy, MD, Principal Investigator, Anesthesiology, Intensive Care Unit and emergency department – Necker Hospital – 149 rue de Sèvres 75015 Paris – France

References

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.

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.

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.

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. Erratum In: Intensive Care Med. 2008 Apr;34(4):783-5.

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.

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