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

Phase 1

Terminated

• Conditions: Renin Angiotensin
• Interventions: Drug: Fludrocortisone; Drug: Hydrocortisone; Drug: Placebo of Hydrocortisone; Drug: Placebo of Fludrocortisone

• Registration Number: NCT00673270
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-05
• Study First Posted: 2008-05-07
• Primary Completion: 2008-10
• Study Completion: 2009-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 13

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Fludrocortisone	Fludrocortisone and Hydrocortisone
1	Hydrocortisone	Fludrocortisone and Hydrocortisone
2	Fludrocortisone	Fludrocortisone and placebo of Hydrocortisone
2	Placebo of Hydrocortisone	Fludrocortisone and placebo of Hydrocortisone
3	Hydrocortisone	Placebo of Fludrocortisone and Hydrocortisone
3	Placebo of Fludrocortisone	Placebo of Fludrocortisone and Hydrocortisone
4	Placebo of Fludrocortisone	Placebo of Fludrocortisone and placebo of Hydrocortisone
4	Placebo of Hydrocortisone	Placebo of Fludrocortisone and placebo of Hydrocortisone

Primary Outcome Measures

Name	Time	Method
Phenylephrine-mean arterial pressure dose-response relationship	Between 1.5 and 3 hours after treatment

Secondary Outcome Measures

Name	Time	Method
Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances	Between administration time and 24 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
Plasma renin, aldosterone, norepinephrine, epinephrine, hydrocortisone, fludrocortisone concentrations	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
Urinary electrolytes excretion	Between administration time and 24 hours after treatment

Trial Locations

Locations (1)

Unité d'Investigation Clinique - Hôpital de Pontchaillou; 🇫🇷 Rennes, France