NCT02140918

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 healthy-volunteers

Timeline
Completed

Started Jul 2014

Typical duration for phase_2 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2016

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

May 12, 2014

Last Update Submit

August 28, 2018

Conditions

Healthy Volunteers

Keywords

FludrocortisoneMineralocorticoidsHemodynamicsPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Phenylephrine mean blood pressor dose-response relationship.

    1.5 hour after fludrocortisone administration

Secondary Outcomes (10)

  • Cardiac systolic and diastolic function assessed par transthoracic echocardiography during phenylephrine administration

    between 1.5 and 2.5 hours after fludrocortisone administration

  • Systemic hemodynamic parameters

    30min before and 1h, 2h, 3h, 4h, 5h, 6h after fludrocortisone administration

  • Arterial stiffness : carotid-femoral pulse wave velocity

    30min before and 1h, 2h, 3h, 4h, 5h, 6h after fludrocortisone administration

  • Central aortic hemodynamic parameters

    30min before and 1h, 2h, 3h, 4h, 5h, 6h after fludrocortisone administration

  • Plasma parameters

    30min before and 1h, 2h, 3h, 4h, 5h, 6h after fludrocortisone administration

  • +5 more secondary outcomes

Study Arms (4)

Fludrocortisone 100 μg

EXPERIMENTAL

* 100 μg/day (25 µg four times daily) of fludrocortisone during 5 days * Investigations the sixth day

Drug: Fludrocortisone 100 μg

Fludrocortisone 200 μg

EXPERIMENTAL

* 200 μg/day (50 µg four times daily) of fludrocortisone during 5 days * Investigations the sixth day

Drug: Fludrocortisone 200 μg

Fludrocortisone 400 μg

EXPERIMENTAL

* 400 μg/day (100 µg four times daily) of fludrocortisone during 5 days * Investigations the sixth day

Drug: Fludrocortisone 400 μg

Placebo

PLACEBO COMPARATOR

* Placebo (four times daily) during 5 days * Investigations the sixth day

Drug: Placebo

Interventions

Fludrocortisone 100 μgDRUG

Fludrocortisone 100 μg/day

Fludrocortisone 100 μg
Fludrocortisone 200 μgDRUG

Fludrocortisone 200 μg/day

Fludrocortisone 200 μg
Fludrocortisone 400 μgDRUG

Fludrocortisone 400 μg/day

Fludrocortisone 400 μg
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 20 to 25 years
  • Body Mass Index between 20 kg/m² and 25 kg/m²
  • Nonsmoker since at least 6 months
  • Normal clinical examination, electrocardiogram and transthoracic echocardiography
  • Normal routine biological parameters
  • Written informed consent

You may not qualify if:

  • History of significant allergy
  • Resting heart rate \< 50 bpm
  • Subjects with abnormal hepatic or renal function, or cardiovascular, pulmonary, endocrine or psychiatric disease
  • Ongoing medication during the study
  • Alcohol consumption more than 30g/day or drug addiction
  • Subject under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Interventions

Fludrocortisone

Intervention Hierarchy (Ancestors)

HydrocortisonePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bruno Laviolle, MD

    Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou

    PRINCIPAL INVESTIGATOR

  • Eric Bellissant, MD, PHD

    Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 16, 2014

Study Start

July 1, 2014

Primary Completion

April 20, 2016

Study Completion

April 20, 2016

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

FR(1)