SepsisMI: Serial Measurement of Capillary Blood Lactate in the Management of Sepsis

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT02180399

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Sepsis

Study Design

Study Type:

Observational

Anticipated 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 :

Feb 1, 2014

Anticipated Primary Completion Date :

Sep 1, 2017

Anticipated Study Completion Date :

Sep 1, 2017

Outcome Measures

Primary Outcome Measures

measurement of capillary blood lactate [72 hours after inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SERVICE DE MED. INTERNE - DIABETE ET MALADIES METABOLIQUES, 1-place de l'Hôpital	Strasbourg		France	67091
2	Service de Médecine Interne - Clinique Médicale B	Strasbourg		France	67091