Clinical trial NCT03831685: Blood Lactate Level for Pre-hospital Orientation of Septic Shock
Official title: Contribution of Pre-hospital Blood Lactate Level for Pre-hospital Orientation of Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Lactate Blood Increase
Keywords: sepsis
lactate
prehospital
prediction
mortality
Lead sponsor: Hôpital Necker-Enfants Malades
Sponsor class: OTHER
Collaborators: name: Fire Brigade Of Paris Emergency Medicine Dept
name: University Hospital, Grenoble
name: University Hospital, Toulouse
name: University Hospital Center of Martinique
First posted: 2019-02-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with septic shock in the pre-hospital setting requiring mobile intensive care unit intervention

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.

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.

Eligibility 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

Primary outcomes:
measure: Mortality after inclusion
timeFrame: 30 days
Secondary outcomes:
measure: Intensive Care Unit length of stay
timeFrame: 90 days
measure: Hospital length of stay
timeFrame: 90 days
measure: Mechanical ventilatory support
timeFrame: 30 days
measure: Hemodynamic support
timeFrame: 30 days
measure: Duration of hemodiaflitration
timeFrame: 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP Necker Enfants Malades
Study officials:
affiliation: APHP - Necker enfants malades Hospital - SAMU Anesthesiology and intensive care unit
name: Romain Jouffroy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marecaux G, Pinsky MR, Dupont E, Kahn RJ, Vincent JL. Blood lactate levels are better prognostic indicators than TNF and IL-6 levels in patients with septic shock. Intensive Care Med. 1996 May;22(5):404-8. doi: 10.1007/BF01712155.
citation: Bakker J, Coffernils M, Leon M, Gris P, Vincent JL. Blood lactate levels are superior to oxygen-derived variables in predicting outcome in human septic shock. Chest. 1991 Apr;99(4):956-62. doi: 10.1378/chest.99.4.956.
citation: Cicarelli DD, Vieira JE, Bensenor FE. [Lactate as a predictor of mortality and multiple organ failure in patients with the systemic inflammatory response syndrome.]. Rev Bras Anestesiol. 2007 Dec;57(6):630-8. doi: 10.1590/s0034-70942007000600005. Portuguese.
citation: Gaieski DF, Goyal M. Serum lactate as a predictor of mortality in emergency department patients with infection: does the lactate level tell the whole story? Ann Emerg Med. 2005 Dec;46(6):561-2; author reply 562. doi: 10.1016/j.annemergmed.2005.07.021. No abstract available.
citation: Mikkelsen ME, Miltiades AN, Gaieski DF, Goyal M, Fuchs BD, Shah CV, Bellamy SL, Christie JD. Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock. Crit Care Med. 2009 May;37(5):1670-7. doi: 10.1097/CCM.0b013e31819fcf68.
citation: Shapiro NI, Howell MD, Talmor D, Nathanson LA, Lisbon A, Wolfe RE, Weiss JW. Serum lactate as a predictor of mortality in emergency department patients with infection. Ann Emerg Med. 2005 May;45(5):524-8. doi: 10.1016/j.annemergmed.2004.12.006.
citation: Arnold RC, Shapiro NI, Jones AE, Schorr C, Pope J, Casner E, Parrillo JE, Dellinger RP, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of early lactate clearance as a determinant of survival in patients with presumed sepsis. Shock. 2009 Jul;32(1):35-9. doi: 10.1097/shk.0b013e3181971d47.