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Rapid rEcognition of COrticosteroid Resistant or sentive Sepsis - RECORDS A Multicentre Concealed‐Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516407-16-00
Acronym
APHP191110
Enrollment
1800
Registered
2024-11-05
Start date
2020-04-10
Completion date
Unknown
Last updated
2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients admitted to the ICU proven or suspected infection as the main diagnosis.

Brief summary

90-Day organ dysfunction, ventilation and vasopressors free survival after randomization, which is a composite of day 90 mortality and survival free days off vasopressors and mechanical ventilation, and with SOFA score > 6

Detailed description

Mortality at 7, 14, 28 day and 6 months., Vasopressor free days: defined as the number of days with permanent hemodynamic stability in the absence of any vasopressor agent, norepinephrine, phenylephrine, epinephrine, dopamine, vasopressine or its analogs, and soever. When a patient will die on vasopressor therapy, the corresponding vasopressor free day will be 0., Mechanical ventilation free days: defined as the number of days with permanent appropriate oxygenation while the patients is extubated and breathing spontaneously, i.e. no need for non invasive ventilation, high flow oxygen or CPAP. Other uses of non-invasive ventilation are not counted. When a patient will die on mechanical ventilation or will be discharge home on mechanical ventilation, the corresponding mechanical ventilation free day will be 0., Organ dysfunction free days: Organ function (including renal function) will be assessed by the SOFA score (Vincent 1996). Organ dysfunction will be defined by a SOFA score of > 6 (Annane 2018). Organ dysfunction free days are defined by the number of days with os total SOFA score of 6 or less. When a patient will die on vasopressor therapy, the corresponding vasopressor free day will be 0., HRQoL in 6-month survivors assessed by the EuroQol-5D (EQ-5D)., Proportion of patients with a decision to withhold and/or withdraw active treatments, ICU and hospital length of stay, Rate of re-admission to the ICU during the 180 days after randomization, Safety endpoints: see protocol

Interventions

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
90-Day organ dysfunction, ventilation and vasopressors free survival after randomization, which is a composite of day 90 mortality and survival free days off vasopressors and mechanical ventilation, and with SOFA score > 6

Secondary

MeasureTime frame
Mortality at 7, 14, 28 day and 6 months., Vasopressor free days: defined as the number of days with permanent hemodynamic stability in the absence of any vasopressor agent, norepinephrine, phenylephrine, epinephrine, dopamine, vasopressine or its analogs, and soever. When a patient will die on vasopressor therapy, the corresponding vasopressor free day will be 0., Mechanical ventilation free days: defined as the number of days with permanent appropriate oxygenation while the patients is extubated and breathing spontaneously, i.e. no need for non invasive ventilation, high flow oxygen or CPAP. Other uses of non-invasive ventilation are not counted. When a patient will die on mechanical ventilation or will be discharge home on mechanical ventilation, the corresponding mechanical ventilation free day will be 0., Organ dysfunction free days: Organ function (including renal function) will be assessed by the SOFA score (Vincent 1996). Organ dysfunction will be defined by a SOFA score of > 6

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026