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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Completion Date

2014-02-28

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.

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Detailed Description

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Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Fludrocortisone

Group Type EXPERIMENTAL

Fludrocortisone

Intervention Type DRUG

50 µg of fludrocortisone per os

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet of placebo per os

Interventions

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Fludrocortisone

50 µg of fludrocortisone per os

Intervention Type DRUG

Placebo

1 tablet of placebo per os

Intervention Type DRUG

Other Intervention Names

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9- alpha- fluorohydrocortisone

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