An observational study in Sepsis and Lactate Blood Increase, sponsored by Hôpital Necker-Enfants Malades. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by Hôpital Necker-Enfants Malades · Observational
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.
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Hôpital Necker-Enfants Malades is the lead sponsor of 22 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with septic shock in the pre-hospital setting requiring mobile intensive care unit intervention
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
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.
Mortality after inclusion
mortality rate
Time frame: 30 days
Intensive Care Unit length of stay
Duration of ICU length of stay
Time frame: 90 days
Hospital length of stay
Duration of Hospital length of stay
Time frame: 90 days
Mechanical ventilatory support
Duration of mechanical ventilation
Time frame: 30 days
Hemodynamic support
Duration of catecholamines' infusion
Time frame: 30 days
Duration of hemodiaflitration
Duration of extra renal support
Time frame: 30 days
Plan to share: Undecided
Started Mar 2018 (actual). Primary completion is estimated for Mar 2022, 48 months after the start.
Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 48 months is above that.
Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Hôpital Necker-Enfants Malades