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

NCT00673270 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2012-03-02

No results posted yet for this study

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.

Conditions

  • Renin Angiotensin

Interventions

DRUG

Fludrocortisone

50 µg of fludrocortisone per os

DRUG

Hydrocortisone

50 mg of intravenous hydrocortisone

DRUG

Placebo of Fludrocortisone

Tablet of placebo of Fludrocortisone

DRUG

Placebo of Hydrocortisone

2 ml of isotonic saline solution

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Bruno LAVIOLLE, MD · Rennes University Hospital

  • Eric BELLISSANT, MD, PhD · Rennes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-10-31
Completion
2009-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00673270 on ClinicalTrials.gov