NCT00673270

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

May 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 2, 2012

Status Verified

March 1, 2012

Enrollment Period

5 months

First QC Date

May 5, 2008

Last Update Submit

March 1, 2012

Conditions

Renin Angiotensin

Outcome Measures

Primary Outcomes (1)

  • Phenylephrine-mean arterial pressure dose-response relationship

    Between 1.5 and 3 hours after treatment

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

Fludrocortisone and Hydrocortisone

Drug: FludrocortisoneDrug: Hydrocortisone

2

EXPERIMENTAL

Fludrocortisone and placebo of Hydrocortisone

Drug: FludrocortisoneDrug: Placebo of Hydrocortisone

3

EXPERIMENTAL

Placebo of Fludrocortisone and Hydrocortisone

Drug: HydrocortisoneDrug: Placebo of Fludrocortisone

4

PLACEBO COMPARATOR

Placebo of Fludrocortisone and placebo of Hydrocortisone

Drug: Placebo of FludrocortisoneDrug: Placebo of Hydrocortisone

Interventions

FludrocortisoneDRUG

50 µg of fludrocortisone per os

12
HydrocortisoneDRUG

50 mg of intravenous hydrocortisone

13
Placebo of FludrocortisoneDRUG

Tablet of placebo of Fludrocortisone

34
Placebo of HydrocortisoneDRUG

2 ml of isotonic saline solution

24

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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.
  • Persons deprived of freedom or under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité d'Investigation Clinique - Hôpital de Pontchaillou

Rennes, 35033, France

Location

MeSH Terms

Interventions

FludrocortisoneHydrocortisone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Bruno LAVIOLLE, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • Eric BELLISSANT, MD, PhD

    Rennes University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
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 5, 2008

First Posted

May 7, 2008

Study Start

May 1, 2008

Primary Completion

October 1, 2008

Study Completion

March 1, 2009

Last Updated

March 2, 2012

Record last verified: 2012-03

Locations

FR(1)