NCT03831685

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
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Hôpital Necker-Enfants Malades · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sepsis
• Lactate Blood Increase

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-03-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2019-02-06
• Last updated: 2019-02-11

Locations

1 site across 1 country: France