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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00673270
First received: May 5, 2008
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  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
 Drug: Fludrocortisone
Drug: Hydrocortisone
Drug: Placebo of Fludrocortisone
Drug: Placebo of Hydrocortisone
 Phase 1
Phase 2

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:

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 ]

Enrollment: 13
Study Start Date: May 2008
Study Completion Date: March 2009
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
  • 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
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: 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: March 1, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Fludrocortisone
Hydrocortisone
 Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013