Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response in Septic Shock (FLUDRO)

Rennes University Hospital

Status and phase: Withdrawn; Phase 3

Conditions: Septic Shock

Treatments: Drug: Fludrocortisone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02069288

EudraCT 2007-007971-18

CIC0203/082

Details and patient eligibility

About

Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. If hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone remains to be elucidated. The purpose of our study is to investigate the effect of a physiological dose of fludrocortisone alone on norepinephrine-mean arterial pressure dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients with septic shock.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over than 18 years old
• Septic shock
• Haemodynamic stability (mean arterial pressure between 70 and 80 mmHg) for at least 1 hour, with a norepinephrine dose less than 0,5 µg/kg/min
• Written informed consent

Exclusion criteria

• Corticotherapy
• Known allergy to Fludrocortisone
• Esophageal or gastric disease
• Pregnant woman
• Inclusion in another clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Fludrocortisone

Treatment:

Drug: Fludrocortisone

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo