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

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ClinicalTrials.gov Identifier: NCT02180399
Recruitment Status : Recruiting
First Posted : July 2, 2014
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease
Sepsis

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Other
Official Title: Role of the Serial Measurement of Capillary Blood Lactate in the Management of Sepsis Outside the Intensive Care
Actual Study Start Date : February 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis




Primary Outcome Measures :
  1. measurement of capillary blood lactate [ Time Frame: 72 hours after inclusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180399


Contacts
Contact: Emmanuel ANDRES, MD, PhD 33 3 88 11 50 66 Emmanuel.ANDRES@chru-strasbourg.fr
Contact: Adrian PURCAREA, MD 33 3 88 11 50 66 adrianpetru.purcarea@chru-strasbourg.fr

Locations
France
SERVICE DE MED. INTERNE - DIABETE ET MALADIES METABOLIQUES, 1-place de l'Hôpital Not yet recruiting
Strasbourg, France, 67091
Contact: Adrian PURCAREA, MD    (33) 03.88.11.67.20    adrianpetru.purcarea@chru-strasbourg.fr   
Service de Médecine Interne - Clinique Médicale B Recruiting
Strasbourg, France, 67091
Contact: Emmanuel ANDRES, MD, PhD    33 3 88 11 50 66    emmanuel.andres@chru-strasbourg.fr   
Contact: Adrian PURCAREA, MD    33 3 88 11 50 66    adrianpetru.purcarea@chru-strasbourg.fr   
Principal Investigator: Emmanuel ANDRES, MD, PhD         
Sub-Investigator: Adrian PURCAREA, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Emmanuel ANDRES, MD, PhD University Hospitals of Strasbourg

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02180399     History of Changes
Other Study ID Numbers: 6031
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017

Keywords provided by University Hospital, Strasbourg, France:
Sepsis
Capillary blood lactate
Serial measurement of capillary

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes