Blood Lactate Level for Pre-hospital Orientation of Septic Shock

• Conditions: Sepsis; Lactate Blood Increase

• Registration Number: NCT03831685
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-03-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-02
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-06
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-11
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality after inclusion	30 days	mortality rate

Secondary Outcome Measures

Name	Time	Method
Intensive Care Unit length of stay	90 days	Duration of ICU length of stay
Hospital length of stay	90 days	Duration of Hospital length of stay
Mechanical ventilatory support	30 days	Duration of mechanical ventilation
Hemodynamic support	30 days	Duration of catecholamines' infusion
Duration of hemodiaflitration	30 days	Duration of extra renal support

Trial Locations

Locations (1)

APHP Necker Enfants Malades; 🇫🇷 Paris, France