Serial Measurement of Capillary Blood Lactate in the Management of Sepsis

Sepsis Clinical Trial

— SepsisMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02180399
• Other study ID #: 6031
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2014
• Last updated: May 18, 2017
• Start date: February 2014
• Est. completion date: September 2017

Study information

• Verified date: May 2017
• Source: University Hospital, Strasbourg, France
• Contact: Emmanuel ANDRES, MD, PhD
• Phone: 33 3 88 11 50 66
• Email: Emmanuel.ANDRES[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of capillary blood lactate		72 hours after inclusion