AFLUCO2
Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression
Sponsor study identifier
Secondary identifiers
interventional
13
1 country
1
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2008
Actual (reported)Study Completion
March 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
May 5, 2008
Actual (reported)May 7, 2008
Actual (reported)October 2008
Actual (reported)March 2009
Actual (reported)Phenylephrine-mean arterial pressure dose-response relationship
Between 1.5 and 3 hours after treatment
Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances
Between administration time and 24 hours after treatment
Central aortic pressures, Augmentation Index (Aix)
Between administration time and 12 hours after treatment
Arterial stiffness: Carotid-femoral Pulse Wave Velocity
Between administration time and 12 hours after treatment
Humeral diameter and distensibility
Between administration time and 12 hours after treatment
Plasma electrolytes, blood glucose, serum creatinine
Between administration time and 24 hours after treatment
Fludrocortisone and Hydrocortisone
Fludrocortisone and placebo of Hydrocortisone
Placebo of Fludrocortisone and Hydrocortisone
50 µg of fludrocortisone per os
50 mg of intravenous hydrocortisone
Unité d'Investigation Clinique - Hôpital de Pontchaillou
Rennes, 35033, France
Bruno LAVIOLLE, MD
Rennes University Hospital
Eric BELLISSANT, MD, PhD
Rennes University Hospital
13 participants (actual enrollment reported by the registry).
First Submitted
May 5, 2008
First Posted
May 7, 2008
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Placebo of Fludrocortisone and placebo of Hydrocortisone
Tablet of placebo of Fludrocortisone
2 ml of isotonic saline solution
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Primary Completion
October 2008
Actual (reported)Study Completion
March 2009
Actual (reported)Last Updated
March 2, 2012
Record last verified: 2012-03
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Source: ClinicalTrials.gov.
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