Blood Lactate Level for Pre-hospital Orientation of Septic Shock

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sepsis, Lactate Blood Increase

Intervention / Treatment
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* Other: Blood sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality after inclusion | mortality rate | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care Unit length of stay | Duration of ICU length of stay | 90 days | 
| Hospital length of stay | Duration of Hospital length of stay | 90 days | 
| Mechanical ventilatory support | Duration of mechanical ventilation | 30 days | 
| Hemodynamic support | Duration of catecholamines' infusion | 30 days | 
| Duration of hemodiaflitration | Duration of extra renal support | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, lactate, prehospital, prediction, mortality