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

Hôpital Necker-Enfants Malades

Status: Unknown

Conditions: Lactate Blood Increase; Sepsis

Treatments: Other: Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT03831685

LAPHSUS study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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