Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression - Full Text View

Sponsored by:	Rennes University Hospital
Information provided by:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00673270

Purpose

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.

Condition	Intervention	Phase
Renin Angiotensin System	Drug: Fludrocortisone Drug: Hydrocortisone Drug: Placebo of Fludrocortisone Drug: Placebo of Hydrocortisone	Phase I Phase II

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Fludrocortisone Fludrocortisone 21-acetate Aldosterone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:

Phenylephrine-mean arterial pressure dose-response relationship [ Time Frame: Between 1.5 and 3 hours after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances [ Time Frame: Between administration time and 24 hours after treatment ] [ Designated as safety issue: No ]
Central aortic pressures, Augmentation Index (Aix) [ Time Frame: Between administration time and 12 hours after treatment ] [ Designated as safety issue: No ]
Arterial stiffness: Carotid-femoral Pulse Wave Velocity [ Time Frame: Between administration time and 12 hours after treatment ] [ Designated as safety issue: No ]
Humeral diameter and distensibility [ Time Frame: Between administration time and 12 hours after treatment ] [ Designated as safety issue: No ]
Plasma electrolytes, blood glucose, serum creatinine [ Time Frame: Between administration time and 24 hours after treatment ] [ Designated as safety issue: Yes ]
Plasma renin, aldosterone, norepinephrine, epinephrine, hydrocortisone, fludrocortisone concentrations [ Time Frame: Between administration time and 24 hours after treatment ] [ Designated as safety issue: No ]
Urinary electrolytes excretion [ Time Frame: Between administration time and 24 hours after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	May 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Fludrocortisone and Hydrocortisone	Drug: Fludrocortisone 50 µg of fludrocortisone per os Drug: Hydrocortisone 50 mg of intravenous hydrocortisone
2: Experimental Fludrocortisone and placebo of Hydrocortisone	Drug: Fludrocortisone 50 µg of fludrocortisone per os Drug: Placebo of Hydrocortisone 2 ml of isotonic saline solution
3: Experimental Placebo of Fludrocortisone and Hydrocortisone	Drug: Hydrocortisone 50 mg of intravenous hydrocortisone Drug: Placebo of Fludrocortisone Tablet of placebo of Fludrocortisone
4: Placebo Comparator Placebo of Fludrocortisone and placebo of Hydrocortisone	Drug: Placebo of Fludrocortisone Tablet of placebo of Fludrocortisone Drug: Placebo of Hydrocortisone 2 ml of isotonic saline solution

Eligibility

Ages Eligible for Study:	20 Years to 30 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Exclusion 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673270

Contacts

Contact: Bruno LAVIOLLE, MD

33-2-9928-3715

bruno.laviolle@chu-rennes.fr

Locations

France
Unité d'Investigation Clinique - Hôpital de Pontchaillou	Recruiting
Rennes, France, 35033
Contact: Fabrice LAINE, MD 33-2-9928-3715 fabrice.laine@chu-rennes.fr
Principal Investigator: Fabrice LAINE, MD

Sponsors and Collaborators

Rennes University Hospital

Investigators

Principal Investigator:	Bruno LAVIOLLE, MD	Rennes University Hospital
Study Chair:	Eric BELLISSANT, MD, PhD	Rennes University Hospital

More Information

Responsible Party:	Rennes University Hospital ( Direction of Clinical Research and Strategy )
Study ID Numbers:	EudraCT 2007-0077969-20, CIC0203/029
Study First Received:	May 5, 2008
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00673270
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Hydrocortisone
Cortisol succinate
Fludrocortisone
Hydrocortisone acetate
Healthy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009