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

February 19, 2014 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Service de Réanimation Chirurgicale - Hôpital de Pontchaillou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
1 tablet of placebo per os
Experimental: 1
Fludrocortisone
Drug: Fludrocortisone
50 µg of fludrocortisone per os
Other Names:
  • 9- alpha- fluorohydrocortisone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Bruno LAVIOLLE, MD, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

December 23, 2013

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2007-007971-18
  • CIC0203/082

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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