Clinical trial NCT02473263: Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock
Official title: Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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" 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.

Primary outcomes:
measure: Number of death
timeFrame: 28 days
Secondary outcomes:
measure: Number of death
timeFrame: 90 days
measure: Number of death
timeFrame: at hospital discharge time, estimated at 90 days
measure: Number of days of stay in intensive care unit
timeFrame: at Intensive Care Unit discharge time, estimated at 90 days
measure: Number of days of stay at hospital
timeFrame: at hospital discharge time, estimated at 90 days
measure: Number of days of vasopressor support
timeFrame: at Intensive Care Unit discharge time, estimated at 90 days
measure: Number of days of mechanical ventilation support
timeFrame: at Intensive Care Unit discharge time, estimated at 90 days
measure: Number of days of renal replacement therapy
timeFrame: at Intensive Care Unit discharge time, estimated at 90 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital
Study officials:
affiliation: Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital - 149 rue de Sèvres 75015 Paris - France
name: Romain Jouffroy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.