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

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ceftriaxone
Piperacillin tazobactam
Norepinephrine
Hydrocortisone
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit focused on measuring Severe septic syndrome, mobile intensive care unit, strategy, antibiotics, hemodynamic optimization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Conventional

Aggressive

Arm Description

No antibiotic administration and no hemodynamic target are required

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

Outcomes

Primary Outcome Measures

Number of death

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2015
Last Updated
March 6, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02473263
Brief Title
Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock
Acronym
SSS
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 9, 2016 (Actual)
Primary Completion Date
February 9, 2019 (Actual)
Study Completion Date
February 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
398 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
No Intervention
Arm Description
No antibiotic administration and no hemodynamic target are required
Arm Title
Aggressive
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Intervention Description
Ceftriaxone 2g IV will be infused in the first 60 minutes, for non nosocomial severe septic syndrome
Intervention Type
Drug
Intervention Name(s)
Piperacillin tazobactam
Intervention Description
Piperacillin/tazobactam 4g IV will be infused in the first 60 minutes, for nosocomial severe septic syndrome
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Norepinephrine will be infused after failure of hemodynamic optimization using vascular fluid loading
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
Hydrocortisone 100mg IV will be infused after failure of hemodynamic optimization using norepinephrine with at least 1.5mg/h
Primary Outcome Measure Information:
Title
Number of death
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Number of death
Time Frame
90 days
Title
Number of death
Time Frame
at hospital discharge time, estimated at 90 days
Title
Number of days of stay in intensive care unit
Time Frame
at Intensive Care Unit discharge time, estimated at 90 days
Title
Number of days of stay at hospital
Time Frame
at hospital discharge time, estimated at 90 days
Title
Number of days of vasopressor support
Time Frame
at Intensive Care Unit discharge time, estimated at 90 days
Title
Number of days of mechanical ventilation support
Time Frame
at Intensive Care Unit discharge time, estimated at 90 days
Title
Number of days of renal replacement therapy
Time Frame
at Intensive Care Unit discharge time, estimated at 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain Jouffroy, MD
Organizational Affiliation
Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital - 149 rue de Sèvres 75015 Paris - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesiology, Intensive Care Unit and emergency department - Necker Hospital
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11794169
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.
Results Reference
background
PubMed Identifier
16941754
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.
Results Reference
background
PubMed Identifier
16625125
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.
Results Reference
background
PubMed Identifier
18058085
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. Erratum In: Intensive Care Med. 2008 Apr;34(4):783-5.
Results Reference
background
PubMed Identifier
15888853
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.
Results Reference
background

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

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