The Multicentre Prospective Observational Study on the Management of Septic Shock
Starting soon
Conditions studied: Septic Shock
In brief
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.
Key facts
- Study ID
- NCT07453901
- Run by
- Bicetre Hospital
- People needed
- 5000
- Starts
- 2026-10-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-03-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- Hospitalization in intensive care unit
- Presence of septic shock, defined by the SEPSIS-3 criteria:
- Suspected or documented infection
- Acute elevation of the SOFA score ≥2 points
- Persistent hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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