Serial Measurement of Capillary Blood Lactate in the Management of Sepsis (SepsisMI)

May 18, 2017 updated by: University Hospital, Strasbourg, France

Role of the Serial Measurement of Capillary Blood Lactate in the Management of Sepsis Outside the Intensive Care

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67091
        • Not yet recruiting
        • SERVICE DE MED. INTERNE - DIABETE ET MALADIES METABOLIQUES, 1-place de l'Hôpital
        • Contact:
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Médecine Interne - Clinique Médicale B
        • Contact:
        • Principal Investigator:
          • Emmanuel ANDRES, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Adrian PURCAREA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measurement of capillary blood lactate
Time Frame: 72 hours after inclusion
72 hours after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Study Director: Emmanuel ANDRES, MD, PhD, University Hospitals of Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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