NCT03831685

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

4 years

First QC Date

February 2, 2019

Last Update Submit

February 7, 2019

Conditions

SepsisLactate Blood Increase

Keywords

sepsislactateprehospitalpredictionmortality

Outcome Measures

Primary Outcomes (1)

  • Mortality after inclusion

    mortality rate

    30 days

Secondary Outcomes (5)

  • Intensive Care Unit length of stay

    90 days

  • Hospital length of stay

    90 days

  • Mechanical ventilatory support

    30 days

  • Hemodynamic support

    30 days

  • Duration of hemodiaflitration

    30 days

Interventions

Blood sampleOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with septic shock in the pre-hospital setting requiring mobile intensive care unit intervention

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP Necker Enfants Malades

Paris, 75015, France

RECRUITING

Related Publications (7)

  • 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.

    PMID: 8796390BACKGROUND

  • 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.

    PMID: 2009802BACKGROUND

  • 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.

    PMID: 19462139BACKGROUND

  • 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.

    PMID: 16308078BACKGROUND

  • 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.

    PMID: 19325467BACKGROUND

  • 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.

    PMID: 15855951BACKGROUND

  • 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.

    PMID: 19533847BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples

MeSH Terms

Conditions

SepsisHyperlactatemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsMetabolic DiseasesNutritional and Metabolic DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Romain Jouffroy, MD

    APHP - Necker enfants malades Hospital - SAMU Anesthesiology and intensive care unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain Jouffroy, MD

CONTACT

+33144495989romain.jouffroy@gmail.com

Benoit Vivien, MD, PhD

CONTACT

+3314492424benoit.vivien@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 6, 2019

Study Start

March 1, 2018

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

February 11, 2019

Record last verified: 2019-02

Locations

FR(1)