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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02069288

Acronym

FLUDRO

Enrollment

Registered

2014-02-24

Start date

Unknown

Completion date

2014-02-28

Last updated

2014-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

fludrocortisone, pharmacology, septic shock

Brief summary

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.

Interventions

DRUGFludrocortisone

50 µg of fludrocortisone per os

DRUGPlacebo

1 tablet of placebo per os

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Norepinephrine-mean arterial pressure dose-response relationship	1.5 h after administration

Secondary

Measure	Time frame
Urinary electrolytes excretion	Each hour during 3 h after administration
Plasma electrolytes, blood glucose, serum creatinine	Each hour during 3 h after administration
Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances	During 3 h after administration
Plasma renin, aldosterone, norepinephrine, epinephrine, fludrocortisone, TNF alpha concentrations	Each hour 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
Central aortic pressures, Augmentation Index (Aix).	During 3 h after administration

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026