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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964690
• Other study ID #: CAL2013
• Secondary ID: 2013-AO1293-42
• Status: Completed
• Phase: N/A
• First received: October 15, 2013
• Last updated: April 26, 2014
• Start date: December 2013
• Est. completion date: April 2014

Study information

• Verified date: January 2014
• Source: Hopital Saint Roch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
France	Hopital Saint Roch	Nice	Alpes-maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Saint Roch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Comparison values of capillary lactate and arterial lactate	Determine if capillary blood lactate may replace laboratory reference method (arterial lactate)	30 minutes after sampling	No
Secondary	Mortality	Determine if capillary lactate value can be use as a mortality predictive tool	Day 28 mortality	No