Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression (AFLUCO2)

March 1, 2012 updated by: Rennes University Hospital

Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression

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 and/or hydrocortisone on phenylephrine-mean arterial pressure dose-response relationship in healthy volunteers with aldosterone suppression induced by intravenous sodium loading.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2
  • Phase 1

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
        • Unité d'Investigation Clinique - 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

16 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men between 20 and 30 years
  • Body Mass Index between 18 kg/m² and 25 kg/m²
  • Normal clinical examination
  • Normal biological variables
  • Normal electrocardiogram and echocardiography
  • Written, voluntary informed consent
  • Non smoker since at least a year

Non-inclusion Criteria:

  • Any history of significant allergy
  • Subjects with abnormal renal, pulmonary, cardiovascular, endocrine or hepatic function
  • Medication during the study
  • Alcohol consumption more than 30g/day or drug addiction
  • Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.
  • Exclusion period mentioned on the Healthy Volunteers National list
  • Persons deprived of freedom or under guardianship

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Fludrocortisone and Hydrocortisone
Drug: Fludrocortisone
50 µg of fludrocortisone per os
Drug: Hydrocortisone
50 mg of intravenous hydrocortisone
Experimental: 2
Fludrocortisone and placebo of Hydrocortisone
Drug: Fludrocortisone
50 µg of fludrocortisone per os
Drug: Placebo of Hydrocortisone
2 ml of isotonic saline solution
Experimental: 3
Placebo of Fludrocortisone and Hydrocortisone
Drug: Hydrocortisone
50 mg of intravenous hydrocortisone
Drug: Placebo of Fludrocortisone
Tablet of placebo of Fludrocortisone
Placebo Comparator: 4
Placebo of Fludrocortisone and placebo of Hydrocortisone
Drug: Placebo of Hydrocortisone
2 ml of isotonic saline solution
Drug: Placebo of Fludrocortisone
Tablet of placebo of Fludrocortisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phenylephrine-mean arterial pressure dose-response relationship
Time Frame: Between 1.5 and 3 hours after treatment
Between 1.5 and 3 hours after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances
Time Frame: Between administration time and 24 hours after treatment
Between administration time and 24 hours after treatment
Central aortic pressures, Augmentation Index (Aix)
Time Frame: Between administration time and 12 hours after treatment
Between administration time and 12 hours after treatment
Arterial stiffness: Carotid-femoral Pulse Wave Velocity
Time Frame: Between administration time and 12 hours after treatment
Between administration time and 12 hours after treatment
Humeral diameter and distensibility
Time Frame: Between administration time and 12 hours after treatment
Between administration time and 12 hours after treatment
Plasma electrolytes, blood glucose, serum creatinine
Time Frame: Between administration time and 24 hours after treatment
Between administration time and 24 hours after treatment
Plasma renin, aldosterone, norepinephrine, epinephrine, hydrocortisone, fludrocortisone concentrations
Time Frame: Between administration time and 24 hours after treatment
Between administration time and 24 hours after treatment
Urinary electrolytes excretion
Time Frame: Between administration time and 24 hours after treatment
Between administration time and 24 hours after treatment

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

Study Start

May 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

May 5, 2008

First Submitted That Met QC Criteria

May 5, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

March 2, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2007-0077969-20
  • CIC0203/029

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.

Subscribe