Evaluation of the hemodynamic effects of fludrocortisone on the pressive response to norepinephrine in patients in septic shock - FLUDROSEPSIS

CHU Rennes0 个研究点目标入组 60 人开始时间: 2021年2月2日最近更新: 2024年7月15日

适应症

试验速览

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•- Adult 18 years of age or older
•- Patient presenting with septic shock for less than 24 hours, as defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) by the association of:
•Sepsis defined as an organ dysfunction caused by an inappropriate host response to infection (increase in SOFA score of at least 2 points following infection),
•Persistent hypotension requiring vasopressor drugs to maintain MAP = 65 mmHg,
•Serum lactate level > 2 mmol/l despite adequate vascular filling.
•- Hemodynamic stability for more than 30 min with mean blood pressure = 65 mmHg and noradrenaline dose = 0.5 µg/kg/min,
•- Consent signed by the patient, relative or legal representative or inclusion under emergency procedure.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Non-inclusion criteria:
•- Ongoing treatment with steroids or other treatment that may act on the hypothalamic-pituitary-adrenal axis,
•- Anaesthetic induction with etomidate in the 6 hours prior to randomization due to its selective inhibitory effect on 11 ß-hydroxylase,
•- Known hypersensitivity to fludrocortisone (or one of its excipients), or tetracosactide (Synacthène®),
•- Disorders of gastric emptying (gastric residue > 800 ml),
•- Pregnant or breastfeeding woman,
•- Concomitant participation in another trial that may interfere with study procedures,
•- A person who is not affiliated to social security ,
•- Known situation of deprivation of liberty (safeguarding of justice), guardianship or curatorship,
•- Patient whose life expectancy is less than 24 hours.
•- Patients under legal protection will be excluded as soon as the investigator is aware of their status.
•- Hemodynamic worsening with noradrenaline dose > 1.5 µg/kg/min before evaluation of the primary endpoint.
•- Catecholamine withdrawal prior to evaluation of the primary endpoint.

发起方