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

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ClinicalTrials.gov Identifier: NCT00673270
Recruitment Status : Terminated
First Posted : May 7, 2008
Last Update Posted : March 2, 2012
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Renin Angiotensin Drug: Fludrocortisone Drug: Hydrocortisone Drug: Placebo of Fludrocortisone Drug: Placebo of Hydrocortisone Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression
Study Start Date : May 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Fludrocortisone
Tablet of placebo of Fludrocortisone

Drug: Placebo of Hydrocortisone
2 ml of isotonic saline solution


Outcome Measures
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Primary Outcome Measures :
  1. Phenylephrine-mean arterial pressure dose-response relationship [ Time Frame: Between 1.5 and 3 hours after treatment ]

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

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673270


Locations
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France
Unité d'Investigation Clinique - Hôpital de Pontchaillou
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Bruno LAVIOLLE, MD Rennes University Hospital
Study Chair: Eric BELLISSANT, MD, PhD Rennes University Hospital
More Information
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00673270    
Other Study ID Numbers: EudraCT 2007-0077969-20
CIC0203/029
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
 Hydrocortisone hemisuccinate
Fludrocortisone
Anti-Inflammatory Agents