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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response, Gastric Mucosal Perfusion and Arterial Stiffness in Septic Shock

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Fludrocortisone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fludrocortisone | Drug: Fludrocortisone<br>* 50 µg of fludrocortisone per os<br>* Other names: 9- alpha- fluorohydrocortisone;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* 1 tablet of placebo per os<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Norepinephrine-mean arterial pressure dose-response relationship |  | 1.5 h after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances |  | During 3 h after administration | 
| Central aortic pressures, Augmentation Index (Aix). |  | During 3 h after administration | 
| Arterial stiffness: Carotid-femoral Pulse Wave Velocity |  | During 3 h after administration | 
| Humeral diameter and distensibility |  | During 3 h after administration | 
| Gastric mucosal perfusion |  | During 3 h after administration | 
| Plasma electrolytes, blood glucose, serum creatinine |  | Each hour during 3 h after administration | 
| Plasma renin, aldosterone, norepinephrine, epinephrine, fludrocortisone, TNF alpha concentrations |  | Each hour during 3 h after administration | 
| Urinary electrolytes excretion |  | Each hour during 3 h after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fludrocortisone, pharmacology, septic shock