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Blood Lactate Level for Pre-hospital Orientation of Septic Shock (LAPHSUS)

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ClinicalTrials.gov Identifier: NCT03831685
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 11, 2019
Sponsor:
Collaborators:
Fire Brigade Of Paris Emergency Medicine Dept
University Hospital, Grenoble
University Hospital, Toulouse
University Hospital Center of Martinique
Information provided by (Responsible Party):
Romain Jouffroy, Hôpital Necker-Enfants Malades

Brief Summary:

In the pre-hospital setting, the severity assessment of septic shock is essential to decide the optimal initial in-hospital level of care. As clinical signs can be faulted, there is a need for an additional element in order to enhance the severity assessment and to decide in-hospital admission in the intensive care unit (ICU) or in the emergency department (ED). Point of care medical device yielding blood lactate levels since the pre-hospital setting may give an easy and valuable element for the severity assessment and the decision-making.

The aim of this study is to provide clinical evidence that the pre-hospital blood lactate level predicts the 30-day mortality of patients with septic shock.


Condition or disease Intervention/treatment
Sepsis Lactate Blood Increase Other: Blood sample

Detailed Description:
This trial is a prospective, observational, non-randomized controlled study. A total of 1000 patients requiring mobile intensive care unit intervention for a septic shock in the pre-hospital setting will be included. Pre-hospital blood lactate levels will not be taken into account to decide patients treatments and/or ED or ICU admission. In the pre-hospital setting, each patient will benefit from 2 measurements of blood lactate level: initial measurement at the first contact, and final measurement at the hospital admission with a specific point of care medical device.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contribution of Pre-hospital Blood Lactate Level for Pre-hospital Orientation of Septic Shock
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Blood sample
    Patients meeting the inclusion criteria and none of the non-inclusion criteria will benefit from 2 venous blood samples in order to precise the initial blood lactate level, e.g. at the first medical contact, and the final blood lactate level, e.g. at the hospital admission.


Primary Outcome Measures :
  1. Mortality after inclusion [ Time Frame: 30 days ]
    mortality rate


Secondary Outcome Measures :
  1. Intensive Care Unit length of stay [ Time Frame: 90 days ]
    Duration of ICU length of stay

  2. Hospital length of stay [ Time Frame: 90 days ]
    Duration of Hospital length of stay

  3. Mechanical ventilatory support [ Time Frame: 30 days ]
    Duration of mechanical ventilation

  4. Hemodynamic support [ Time Frame: 30 days ]
    Duration of catecholamines' infusion

  5. Duration of hemodiaflitration [ Time Frame: 30 days ]
    Duration of extra renal support


Biospecimen Retention:   Samples Without DNA
Venous blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with septic shock in the pre-hospital setting requiring mobile intensive care unit intervention
Criteria

Inclusion Criteria:

  • Age > 18 years either sex
  • Severe sepsis according to the French anesthesiology and intensive care society (SFAR) and intensive care society (SRLF) conference 2005 defined by the existence of an infectious disease and at least one the following:

    • Low blood pressure prior to volume expansion
    • Glasgow coma scale < 13
    • Skin mottling score > 2
  • Septic shock according to the French anesthesiology and intensive care society (SFAR) and intensive care society (SRLF) conference 2005 definition

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Serious comorbid conditions with a not to be reanimated status known since pre-hospital setting
  • Patients with guardianship or curator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831685


Contacts
Contact: Romain Jouffroy, MD +33144495989 romain.jouffroy@gmail.com
Contact: Benoit Vivien, MD, PhD +3314492424 benoit.vivien@aphp.fr

Locations
France
APHP Necker Enfants Malades Recruiting
Paris, France, 75015
Contact: Romain Jouffroy, MD    +3314495989    romain.jouffroy@aphp.fr   
Contact: Benoit Vivien, MD, PhD    +33144492424    benoit.vivien@aphp.fr   
Principal Investigator: Jean Pierre Tourtier, MD, PhD         
Principal Investigator: Guillaume Debaty, MD, PhD         
Principal Investigator: Vincent Bounes, MD, PhD         
Principal Investigator: Papa Gueye Ngalgou, MD, PhD         
Sponsors and Collaborators
Hôpital Necker-Enfants Malades
Fire Brigade Of Paris Emergency Medicine Dept
University Hospital, Grenoble
University Hospital, Toulouse
University Hospital Center of Martinique
Investigators
Principal Investigator: Romain Jouffroy, MD APHP - Necker enfants malades Hospital - SAMU Anesthesiology and intensive care unit

Publications:

Responsible Party: Romain Jouffroy, PI, Hôpital Necker-Enfants Malades
ClinicalTrials.gov Identifier: NCT03831685     History of Changes
Other Study ID Numbers: LAPHSUS study
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Romain Jouffroy, Hôpital Necker-Enfants Malades:
sepsis
lactate
prehospital
prediction
mortality

Additional relevant MeSH terms:
Sepsis
Shock, Septic
Hyperlactatemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Metabolic Diseases
Signs and Symptoms