Blood Lactate Level for Pre-hospital Orientation of Septic Shock

NCT ID: NCT03831685

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2022-03-01

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.

Conditions

Sepsis; Lactate Blood Increase

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fire Brigade Of Paris Emergency Medicine Dept

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

University Hospital Center of Martinique

OTHER

Sponsor Role: collaborator

Hôpital Necker-Enfants Malades

OTHER

Sponsor Role: lead

Responsible Party

Romain Jouffroy

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Romain Jouffroy, MD

Role: PRINCIPAL_INVESTIGATOR

APHP - Necker enfants malades Hospital - SAMU Anesthesiology and intensive care unit

Locations

APHP Necker Enfants Malades

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Romain Jouffroy, MD

Role: CONTACT

romain.jouffroy@gmail.com

+33144495989

Benoit Vivien, MD, PhD

Role: CONTACT

benoit.vivien@aphp.fr

+3314492424

Facility Contacts

Romain Jouffroy, MD

Role: primary

romain.jouffroy@aphp.fr

+3314495989

Benoit Vivien, MD, PhD

Role: backup

benoit.vivien@aphp.fr

+33144492424

References

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.

Reference Type: BACKGROUND

PMID: 8796390 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2009802 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19462139 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16308078 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19325467 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15855951 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19533847 (View on PubMed)

Other Identifiers

LAPHSUS study

Identifier Type: -

Identifier Source: org_study_id