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

Sponsor

Hopital Saint Roch (Other)

Overall Status

Completed

CT.gov ID

NCT01964690

Collaborator

(none)

103

Enrollment

Location

Duration (Months)

25.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

103 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Outcome Measures

Primary Outcome Measures

Lactate value [At admission in emergency department]
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*).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Saint Roch	Nice	Alpes-maritimes	France	06000

Sponsors and Collaborators

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