The Multicentre Prospective Observational Study on the Management of Septic Shock
ConditionSeptic Shock
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBicetre Hospital
About this trial
Although there are published guidelines for the management of shock in general and septic shock in particular, the extent to which these guidelines are adhered to or achievable is unknown. Our study aims to describe, in a large population of critical care patients, the management procedures for septic shock, the applicability of existing guidelines, and the characteristics of the centres.
The primary objective is to assess current clinical practices for the treatment and monitoring of patients with septic shock.
The secondary objectives are to investigate the association of current clinical practices for the treatment and monitoring with 28-day all-cause mortality, to assess the association of current clinical practices for the treatment and monitoring with other outcomes, including 90-day all-cause mortality, ICU length of stay, days without renal replacement therapy, days without vasopressors support and days without invasive mechanical ventilation, to assess the factors that influence the disparity of practices, among the severity of the patients, the country, the availability of drugs and devices and to measure the relative frequency of balanced fluid and isotonic saline administration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Hospitalization in intensive care unit
Suspected or documented infection
Acute elevation of the SOFA score ≥2 points
Disqualifiers
Refusal to participate by the patient's relatives or the patient themselves.
Patient already hospitalized in the ICU at the time of inclusion. It should be noted that prior inclusion in the study does not constitute an exclusion criterion.
Trial population
Patients ≥18 years, hospitalization in intensive care unit with a septic shock
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 1 trial groupGroup A: septic shock patients
Trial outcomes
Primary outcomes
1
clinical practices for the treatment and monitoring of patients with septic shock
To assess current clinical practices for the treatment and monitoring, including sequence of their use, of patients with septic shock
Time frame
up to day 90Secondary outcomes
1
association of clinical practices for the treatment with 28-day all-cause mortality
To investigate the association of current clinical practices for the treatment and monitoring with 28-day all-cause mortality.
Time frame
up to day 902
association of clinical practices for the hemodynamic monitoring with 28-day all-cause mortality
To investigate the association of current clinical practices for the hemodynamic monitoring with 28-day all-cause mortality.
Time frame
up to day 903
association of clinical practices for the treatment and monitoring with 90-day all-cause mortality
To investigate the association of current clinical practices for the treatment and monitoring with 90-day all-cause mortality
Time frame
day 904
association of clinical practices for the treatment and monitoring with days without renal replacement therapy
To investigate the association of current clinical practices for the treatment and monitoring with days without renal replacement therapy
Time frame
day 90Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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