NCT02180399

Brief Summary

Determination of capillary lactate by using "point-of-care" technique is accessible, fast and allows to quantify the circulatory and metabolic dysfunction caused by sepsis. Compared to conventional assay techniques in arterial blood, capillary assay technique may have an increased susceptibility to metabolic alterations induced by sepsis in its initial stages. This increased sensitivity is not necessarily relevant in the management of the most serious patients for whom the diagnosis is obvious, but it could be very useful in patients for whom a diagnosis of severe sepsis or shock have not yet been adopted, particularly to help better identify patients who would require intensive management and avoid the installation of these serious disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

3.7 years

First QC Date

February 5, 2014

Last Update Submit

September 4, 2025

Conditions

Keywords

SepsisCapillary blood lactateSerial measurement of capillary

Outcome Measures

Primary Outcomes (1)

  • measurement of capillary blood lactate

    72 hours after inclusion

Eligibility Criteria

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

All patients over age 18 with an acute systemic inflammatory response syndrome array of presumed infectious not yet been treated.

You may qualify if:

  • Age ≥ 18 years
  • Installation without any plausible explanation of at least one of the following clinical criteria:
  • Chills, fever, mottling, respiratory rate\> 20/min; Sat02 \< 90% or \> 94% with more than 4l O2, heart rate \> 90/min,systolic blood pressure \< 100 mmHg or 40 mmHg lower compared with normal values, Glasgow coma score \< 14. or: .a combination of two (or more) of clinical and laboratory criteria for sepsis.
  • Signed informed consent form

You may not qualify if:

  • Need in its current treatment of aerosol administration of beta agonists at a frequency greater than one per 8 hours;
  • Targeted therapeutic measures have already stated for more than 60 minutes;
  • Diagnosis other than Sepsis;
  • Malignant neoplasm or other progressive disease and expected survival was less than 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SERVICE DE MED. INTERNE - DIABETE ET MALADIES METABOLIQUES, 1-place de l'Hôpital

Strasbourg, 67091, France

Location

Service de Médecine Interne - Clinique Médicale B

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Emmanuel ANDRES, MD, PhD

    University Hospitals of Strasbourg

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2014

First Posted

July 2, 2014

Study Start

February 1, 2014

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

September 5, 2025

Record last verified: 2025-09

Locations