Informations générales (source: ClinicalTrials.gov)
Evaluation of the Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline in Septic Shock Patients (FLUDROSEPSIS)
Interventional
Phase 2/Phase 3
Rennes University Hospital (Voir sur ClinicalTrials)
mars 2022
décembre 2024
29 juin 2024
The benefit of low-dose steroids in septic shock is still debated today, especially with
mineralocorticoids. Fludrocortisone is a synthetic mineralocorticoid, an analogue of
aldosterone, which has shown, in combination with hydrocortisone, a favorable effect on
the mortality of septic shock patients with relative adrenal insufficiency. In a previous
study in healthy volunteers, we showed for the first time that fludrocortisone at a dose
of 400 μg per day significantly improved the pressor response to phenylephrine. These
results confirm the observations reported in rats with endotoxin shock, where
fludrocortisone was shown to significantly increase blood pressure and contractile
response to phenylephrine. These encouraging results argue for a potential vascular
beneficial effect of fludrocortisone and need to be confirmed in a population of septic
shock patients. In this context, we aimed to evaluate the effect of oral administration
of 100 μg every 6 hours of fludrocortisone on vascular responsiveness to noradrenaline in
septic shock patients.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Rennes University Hospital - Intensive Care unit - 35033 - Rennes - Bretagne - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Age > 18 years
- Patient with septic shock for less than 48 hours, defined 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,
- 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
- Age > 18 years
- Patient with septic shock for less than 48 hours, defined 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,
- 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
- 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.