Clinical trial NCT01964690: Lactate Use as Triage Tool in Sepsis : Veinous, Capillary or Arterial?
Official title: Lactate and Sepsis : What Dosage Use as Triage Tool in Emergency Department for Patients With Suspected Infection.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Lactate
Sepsis
Capillary lactate
Venous lactate
Quick test
Lead sponsor: Hopital Saint Roch
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected infection in emergency department (admission time)

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lactate value
timeFrame: At admission in emergency department
Secondary outcomes:
measure: Comparison values of capillary lactate and arterial lactate
timeFrame: 30 minutes after sampling
measure: Mortality
timeFrame: Day 28 mortality
Other outcomes:
Locations:
city: Nice
country: France
facility: Hopital Saint Roch
state: Alpes-maritimes
Study officials:
affiliation: Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
name: Contenti Julie, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Nice, France
name: Jacques Levraut, PD,MD
role: STUDY_DIRECTOR
References:
citation: 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.