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

Condition(s) targeted: Severe Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit

Intervention: Ceftriaxone (Drug); Piperacillin tazobactam (Drug); Norepinephrine (Drug); Hydrocortisone (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Romain Jouffroy, MD, Principal Investigator, Affiliation: Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital - 149 rue de Sèvres 75015 Paris - France

Overall contact:
Romain Jouffroy, MD, Phone: +33 1 44 49 54 07, Email: romain.jouffroy@nck.aphp.fr

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

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of death

Secondary outcome:

Number of death

Number of death

Number of days of stay in intensive care unit

Number of days of stay at hospital

Number of days of vasopressor support

Number of days of mechanical ventilation support

Number of days of renal replacement therapy

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 menigitis. Hemodynamic optimization is not a standard of care and no recommandation 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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"

- Fulminans purpura

- True allergy to beta-lactam

Romain Jouffroy, MD, Phone: +33 1 44 49 54 07, Email: romain.jouffroy@nck.aphp.fr

Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital, Paris 75015, France; Not yet recruiting
Romain Jouffroy, MD, Phone: +33 1 44 49 54 07, Email: romain.jouffroy@nck.aphp.fr
Sophie Le Guen, Master, Phone: +33 1 44 49 43 27, Email: sophie.le-guen@nck.aphp.fr

Related publications:

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.

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.

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.

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. 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.

Starting date: September 2015
Last updated: June 15, 2015