Lactate Use as Triage Tool in Sepsis : Veinous, Capillary or Arterial?

Lactate and Sepsis : What Dosage Use as Triage Tool in Emergency Department for Patients With Suspected Infection.

Severe sepsis and septic shocks are increasingly codified. A biomarker as Lactate is very interesting to detect those situations. Usually, lactate used is arterial but results are often too slow to obtain if we want to respect Surviving Sepsis Campaign guidelines. Some analyzers (EKF diagnostics Lactate Scout*) can give results in 15 seconds.

We hypothesized that capillary lactate, easy to sample, tested with this analyzer may detect earlier those infections states and we want to find the most accurate site to detect severe sepsis (capillary, venous or arterial sample).

Study Overview

• Status: Completed
• Conditions: Sepsis

Detailed Description

Actually, patients presenting a sepsis with arterial lactate> 2 mmol.l-1 must be considered as criticals, and if lactate> 4 mmol.l-1 as septic shock. However, results are usually slow to obtain, especially if we want to respect the Surving Sepsis Campaign, which preconize antibiotic as soon as possible (first hour).

In admission room, arterial sample can't be easily done and usual results need more than 30 minutes. On the contrary, using analyzers like "EKF diagnostics Lactate Scout*" can give results faster with capillary blood (15 seconds). We will compare this results with both veinous and arterial lactate.

• For primary outcome, we will determine the most accurate value of capillary or veinous lactate that may be able to detect critical patient suspected of infection.
• for secondary outcomes, we will determine if quick capillary lactate test may replace arterial lactate in this indication and be able to predict mortality.

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• France
  • Alpes-maritimes
    • Nice, Alpes-maritimes, France, 06000
      • Hôpital Saint Roch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected infection in emergency department (admission time)

Description

Inclusion Criteria:

• Age >18 years
• S.I.R.S : 2 or more criteria (fever > 38.3°C or hypothermia (core temperature < 36°C) heart rate > 90.min-1, tachypnea, altered mental status)
• Suspected infection

Exclusion Criteria:

• Arterial sample by laboratory reference method no available

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactate value	Determine the most accurate value of capillary or venous lactate that may be able to early detect patients with severe sepsis or septic shock, using quick test (EKF diagnostics Lactate scout*).	At admission in emergency department

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison values of capillary lactate and arterial lactate	Determine if capillary blood lactate may replace laboratory reference method (arterial lactate)	30 minutes after sampling
Mortality	Determine if capillary lactate value can be use as a mortality predictive tool	Day 28 mortality

Collaborators and Investigators

• Sponsor: Hopital Saint Roch
• Investigators: Principal Investigator: Contenti Julie, M.D, Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences; Study Director: Jacques Levraut, PD,MD, CHU de Nice, France

Publications and helpful links

General Publications

• Contenti J, Corraze H, Lemoel F, Levraut J. Effectiveness of arterial, venous, and capillary blood lactate as a sepsis triage tool in ED patients. Am J Emerg Med. 2015 Feb;33(2):167-72. doi: 10.1016/j.ajem.2014.11.003.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 15, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (Estimate): October 17, 2013

Study Record Updates

• Last Update Posted (Estimate): April 29, 2014
• Last Update Submitted That Met QC Criteria: April 26, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Sepsis; Lactate; Capillary lactate; Venous lactate; Quick test
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: CAL2013; 2013-AO1293-42 (Other Identifier: ANSM)