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

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

— SSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473263
• Other study ID #: 2014-A01030-47
• Status: Completed
• Phase: Phase 3
• Start date: May 9, 2016
• Est. completion date: February 9, 2019

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: February 9, 2019
• Est. primary completion date: February 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Severe Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit
• Shock
• Shock, Septic
• Systemic Inflammatory Response Syndrome
• Toxemia

Intervention

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

Locations

Country	Name	City	State
France	Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of death		28 days
Secondary	Number of death		90 days
Secondary	Number of death		at hospital discharge time, estimated at 90 days
Secondary	Number of days of stay in intensive care unit		at Intensive Care Unit discharge time, estimated at 90 days
Secondary	Number of days of stay at hospital		at hospital discharge time, estimated at 90 days
Secondary	Number of days of vasopressor support		at Intensive Care Unit discharge time, estimated at 90 days
Secondary	Number of days of mechanical ventilation support		at Intensive Care Unit discharge time, estimated at 90 days
Secondary	Number of days of renal replacement therapy		at Intensive Care Unit discharge time, estimated at 90 days