Blood Lactate Level for Pre-hospital Orientation of Septic Shock

Sepsis Clinical Trial

— LAPHSUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03831685
• Other study ID #: LAPHSUS study
• Status: Recruiting
• Start date: March 1, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2019
• Source: Hôpital Necker-Enfants Malades
• Contact: Romain Jouffroy, MD
• Phone: +33144495989
• Email: romain.jouffroy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlactatemia
• Lactate Blood Increase
• Sepsis
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
France	APHP Necker Enfants Malades	Paris

Sponsors (5)

Lead Sponsor	Collaborator
Hôpital Necker-Enfants Malades	Fire Brigade Of Paris Emergency Medicine Dept, University Hospital Center of Martinique, University Hospital, Grenoble, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

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. — View Citation

Cicarelli DD, Vieira JE, Benseñor 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. Portuguese. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality after inclusion	mortality rate	30 days
Secondary	Intensive Care Unit length of stay	Duration of ICU length of stay	90 days
Secondary	Hospital length of stay	Duration of Hospital length of stay	90 days
Secondary	Mechanical ventilatory support	Duration of mechanical ventilation	30 days
Secondary	Hemodynamic support	Duration of catecholamines' infusion	30 days
Secondary	Duration of hemodiaflitration	Duration of extra renal support	30 days