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Fludrocortisone in Healthy Volunteers (AFLUCO4)

NCT02140918 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-08-29

No results posted yet for this study

Summary

Fludrocortisone, in association with hydrocortisone, has demonstrated an improvement in survival in septic shock patients with relative adrenal insufficiency. However, the utility of low doses of steroids and in particular of mineralocorticoids in septic shock is still discussed.

The purpose of the investigators study is to investigate the effects of 3 increasing doses of fludrocortisone (100 μg, 200 μg, 400 μg) in order to determine which dose allows the best pressor response to phenylephrine in healthy volunteers, and simultaneously assess their respective hemodynamic and biological effects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Fludrocortisone 100 μg

Fludrocortisone 100 μg/day

DRUG

Fludrocortisone 200 μg

Fludrocortisone 200 μg/day

DRUG

Fludrocortisone 400 μg

Fludrocortisone 400 μg/day

DRUG

Placebo

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Bruno Laviolle, MD · Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou

  • Eric Bellissant, MD, PHD · Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-07-01
Primary Completion
2016-04-20
Completion
2016-04-20

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT02140918 on ClinicalTrials.gov