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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Lactate Blood Increase
• Intervention / Treatment: Other: Blood sample

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Romain Jouffroy, MD; Phone Number: +33144495989; Email: romain.jouffroy@gmail.com
• Study Contact Backup: Name: Benoit Vivien, MD, PhD; Phone Number: +3314492424; Email: benoit.vivien@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • APHP Necker Enfants Malades
    • Contact: Benoit Vivien, MD, PhD; Phone Number: +33144492424; Email: benoit.vivien@aphp.fr
    • Contact: Romain Jouffroy, MD; Phone Number: +3314495989; Email: romain.jouffroy@aphp.fr
    • Principal Investigator: Jean Pierre Tourtier, MD, PhD
    • Principal Investigator: Guillaume Debaty, MD, PhD
    • Principal Investigator: Vincent Bounes, MD, PhD
    • Principal Investigator: Papa Gueye Ngalgou, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with septic shock in the pre-hospital setting requiring mobile intensive care unit intervention

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hôpital Necker-Enfants Malades
• Collaborators: University Hospital, Grenoble; University Hospital, Toulouse; University Hospital Center of Martinique; Fire Brigade Of Paris Emergency Medicine Dept
• Investigators: Principal Investigator: Romain Jouffroy, MD, APHP - Necker enfants malades Hospital - SAMU Anesthesiology and intensive care unit

Publications and helpful links

General Publications

• Shapiro NI, Howell MD, Talmor D, Nathanson LA, Lisbon A, Wolfe RE, Weiss JW. Serum lactate as a predictor of mortality in emergency department patients with infection. Ann Emerg Med. 2005 May;45(5):524-8. doi: 10.1016/j.annemergmed.2004.12.006.
• Marecaux G, Pinsky MR, Dupont E, Kahn RJ, Vincent JL. Blood lactate levels are better prognostic indicators than TNF and IL-6 levels in patients with septic shock. Intensive Care Med. 1996 May;22(5):404-8. doi: 10.1007/BF01712155.
• Bakker J, Coffernils M, Leon M, Gris P, Vincent JL. Blood lactate levels are superior to oxygen-derived variables in predicting outcome in human septic shock. Chest. 1991 Apr;99(4):956-62. doi: 10.1378/chest.99.4.956.
• Cicarelli DD, Vieira JE, Bensenor FE. [Lactate as a predictor of mortality and multiple organ failure in patients with the systemic inflammatory response syndrome.]. Rev Bras Anestesiol. 2007 Dec;57(6):630-8. doi: 10.1590/s0034-70942007000600005. Portuguese.
• Gaieski DF, Goyal M. Serum lactate as a predictor of mortality in emergency department patients with infection: does the lactate level tell the whole story? Ann Emerg Med. 2005 Dec;46(6):561-2; author reply 562. doi: 10.1016/j.annemergmed.2005.07.021. No abstract available.
• Mikkelsen ME, Miltiades AN, Gaieski DF, Goyal M, Fuchs BD, Shah CV, Bellamy SL, Christie JD. Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock. Crit Care Med. 2009 May;37(5):1670-7. doi: 10.1097/CCM.0b013e31819fcf68.
• Arnold RC, Shapiro NI, Jones AE, Schorr C, Pope J, Casner E, Parrillo JE, Dellinger RP, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of early lactate clearance as a determinant of survival in patients with presumed sepsis. Shock. 2009 Jul;32(1):35-9. doi: 10.1097/shk.0b013e3181971d47.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: February 2, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: sepsis; mortality; prediction; lactate; prehospital
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlactatemia
• Other Study ID Numbers: LAPHSUS study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No