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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression

Resource links provided by NLM:

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

U.S. FDA Resources

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
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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

Locations

France
Unité d'Investigation Clinique - Hôpital de Pontchaillou
Rennes, France, 35033

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

No publications provided

Responsible Party:	Direction of Clinical Research and Strategy, Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00673270 History of Changes
Other Study ID Numbers:	EudraCT 2007-0077969-20, CIC0203/029
Study First Received:	May 5, 2008
Last Updated:	July 30, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Cortisol succinate
Hydrocortisone acetate
Fludrocortisone
Hydrocortisone

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012