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

NCT ID: NCT01964690

Last Updated: 2014-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Saint Roch

OTHER

Sponsor Role lead

Responsible Party

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Contenti Julie

AFERSAU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Contenti Julie, M.D

Role: PRINCIPAL_INVESTIGATOR

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

Jacques Levraut, PD,MD

Role: STUDY_DIRECTOR

CHU de Nice, France

Locations

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Hopital Saint Roch

Nice, Alpes-maritimes, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 25432592 (View on PubMed)

Other Identifiers

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2013-AO1293-42

Identifier Type: OTHER

Identifier Source: secondary_id

CAL2013

Identifier Type: -

Identifier Source: org_study_id

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