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Blood Lactate Level for Pre-hospital Orientation of Septic Shock

Contribution of Pre-hospital Blood Lactate Level for Pre-hospital Orientation of Septic Shock

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03831685
Acronym
LAPHSUS
Enrollment
1000
Registered
2019-02-06
Start date
2018-03-01
Completion date
2022-03-01
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactate Blood Increase, Sepsis

Keywords

sepsis, lactate, prehospital, prediction, mortality

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.

Interventions

OTHERBlood 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.

Sponsors

Fire Brigade Of Paris Emergency Medicine Dept
CollaboratorOTHER
University Hospital, Grenoble
CollaboratorOTHER
University Hospital, Toulouse
CollaboratorOTHER
University Hospital Center of Martinique
CollaboratorOTHER
Hôpital Necker-Enfants Malades
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality after inclusion30 daysmortality rate

Secondary

MeasureTime frameDescription
Intensive Care Unit length of stay90 daysDuration of ICU length of stay
Hospital length of stay90 daysDuration of Hospital length of stay
Mechanical ventilatory support30 daysDuration of mechanical ventilation
Hemodynamic support30 daysDuration of catecholamines' infusion
Duration of hemodiaflitration30 daysDuration of extra renal support

Countries

France

Contacts

Primary ContactRomain Jouffroy, MD
romain.jouffroy@gmail.com+33144495989
Backup ContactBenoit Vivien, MD, PhD
benoit.vivien@aphp.fr+3314492424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026