NCT01964690

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 29, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

October 15, 2013

Last Update Submit

April 26, 2014

Conditions

Keywords

LactateSepsisCapillary lactateVenous lactateQuick test

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Comparison values of capillary lactate and arterial lactate

    30 minutes after sampling

  • Mortality

    Day 28 mortality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected infection in emergency department (admission time)

You may qualify if:

  • 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

You may not qualify if:

  • Arterial sample by laboratory reference method no available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Roch

Nice, Alpes-maritimes, 06000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Contenti Julie, M.D

    Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences

    PRINCIPAL INVESTIGATOR
  • Jacques Levraut, PD,MD

    CHU de Nice, France

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
AFERSAU

Study Record Dates

First Submitted

October 15, 2013

First Posted

October 17, 2013

Study Start

December 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 29, 2014

Record last verified: 2014-01

Locations