Sepsis Clinical Trial
— StraSEPOfficial title:
Comparing Prognostic Performance of SEPSIS 2 and SEPSIS 3 Strategies at the Emergency Service
NCT number | NCT03355833 |
Other study ID # | 2016-05Obs-CHRMT |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | December 2016 |
Verified date | November 2017 |
Source | Centre Hospitalier Régional Metz-Thionville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In 2016, the Third International Consensus proposed a new strategy to screen aggravating risk in patients with septic shock. This strategy is based on quick-SOFA and the SOFA score. The main objective is to compare the prognostic performance of SEPSIS 3 against the previous strategy SEPSIS 2 to predict the admission in intensive care unit or the intra-hospital death.
Status | Completed |
Enrollment | 228 |
Est. completion date | December 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged of 18 years or more - Initiation of one or more antibiotics in the Accident and Emergency Department in the Metz-Thionville hospital (CHR) site Mercy, for curative purpose, regardless of the infectious aetiology - Hospitalized in the CHR Metz-Thionville thereafter Exclusion Criteria: - Minors patients - Absence of antibiotic treatment initiated in the Emergency department - Prescription of antibiotic treatment in the emergency department for preventive purpose - Transferred by hospitalisation service of CHR Metz-Thionville in the emergency department - Absence of hospitalisation following their passage through the emergency department - Transferred to hospitalisation in an other establishment - Presence, at the admission, of an antibiotic treatment - Patients deceased in the emergency department |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional Metz-Thionville |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intrinsic and Extrinsic properties of SEPSIS 3 strategy | The percentage of patients with high qSOFA score (2 or more) who were admitted in intensive care unit or who have died during their stay in hospital and rather the percentage of patients with a small qSOFA score who survived without passing through intensive care unit | Day 1 | |
Secondary | Correlation between lactate levels and mortality | lactate levels at their admission | Day 1 |
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