Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline Septic Shock Patients (FLUDROSEPSIS)

This is an interventional treatment trial for Septic Shock Read More

Inclusion Criteria:

• Age > 18 years

• Patient with septic shock for less than 24 hours, defined according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) by the combination of:

  • Sepsis defined as organ dysfunction caused by an inappropriate host response to infection (increase in SOFA score of at least 2 points secondary to infection),
  • Persistent hypotension requiring vasopressor drugs to maintain mean arterial pressure ≥ 65 mmHg,
  • Serum lactate level > 2 mmol/l despite adequate vascular filling.
• Hemodynamic stability for >30 min with mean arterial pressure ≥ 65 mmHg and noradrenaline dose ≤ 0.5 μg/kg/min,
• Consent signed by the patient, family member, or legal representative or inclusion under emergency procedure,
• Negative to a diagnostic test for SARS-CoV2 less than 72 hours old; the test used must be on the the list published on the Ministry of Solidarity and Health website

Non-inclusion Criteria:

• Current treatment with steroids or other treatment that may affect the hypothalamic-pituitary-adrenal axis,
• Anesthetic induction with etomidate within 6 hours prior to randomization given its selective inhibitory effect on 11 β-hydroxylase,
• Known hypersensitivity to fludrocortisone (or any of its excipients), or to tetracosactide (Synacthen®),
• Disturbed gastric emptying (gastric residue > 500 ml) in the absence of an alternative route of administration available (naso-jejunal tube or jejunostomy),
• Pregnant or nursing woman,
• Patient participating in another trial, possibly interfering with the study procedures,
• Person not affiliated to a social security system,
• Known situation of deprivation of freedom (safeguard of justice), guardianship or curatorship,
• Patient with a life expectancy of less than 24 hours.
• Patient with known or suspected SARS-CoV2 pneumonia

Exclusion criteria:

• Patients under court 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 end point.
• Catecholamine withdrawal before evaluation of the primary end point.