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Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response in Septic Shock (FLUDRO)

Primary Purpose

Septic Shock

Status
Withdrawn
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Fludrocortisone
Placebo
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring fludrocortisone, pharmacology, septic shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over than 18 years old
  • Septic shock
  • Haemodynamic stability (mean arterial pressure between 70 and 80 mmHg) for at least 1 hour, with a norepinephrine dose less than 0,5 µg/kg/min
  • Written informed consent

Exclusion Criteria:

  • Corticotherapy
  • Known allergy to Fludrocortisone
  • Esophageal or gastric disease
  • Pregnant woman
  • Inclusion in another clinical trial

Sites / Locations

  • Service de Réanimation Chirurgicale - Hôpital de Pontchaillou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Fludrocortisone

Placebo

Outcomes

Primary Outcome Measures

Norepinephrine-mean arterial pressure dose-response relationship

Secondary Outcome Measures

Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances
Central aortic pressures, Augmentation Index (Aix).
Arterial stiffness: Carotid-femoral Pulse Wave Velocity
Humeral diameter and distensibility
Gastric mucosal perfusion
Plasma electrolytes, blood glucose, serum creatinine
Plasma renin, aldosterone, norepinephrine, epinephrine, fludrocortisone, TNF alpha concentrations
Urinary electrolytes excretion

Full Information

First Posted
December 23, 2013
Last Updated
February 19, 2014
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02069288
Brief Title
Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response in Septic Shock
Acronym
FLUDRO
Official Title
Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response, Gastric Mucosal Perfusion and Arterial Stiffness in Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Problems of drugs supply by the manufacturer
Study Start Date
undefined (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 alone on norepinephrine-mean arterial pressure dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients with septic shock.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
fludrocortisone, pharmacology, septic shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Fludrocortisone
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Fludrocortisone
Other Intervention Name(s)
9- alpha- fluorohydrocortisone
Intervention Description
50 µg of fludrocortisone per os
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tablet of placebo per os
Primary Outcome Measure Information:
Title
Norepinephrine-mean arterial pressure dose-response relationship
Time Frame
1.5 h after administration
Secondary Outcome Measure Information:
Title
Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances
Time Frame
During 3 h after administration
Title
Central aortic pressures, Augmentation Index (Aix).
Time Frame
During 3 h after administration
Title
Arterial stiffness: Carotid-femoral Pulse Wave Velocity
Time Frame
During 3 h after administration
Title
Humeral diameter and distensibility
Time Frame
During 3 h after administration
Title
Gastric mucosal perfusion
Time Frame
During 3 h after administration
Title
Plasma electrolytes, blood glucose, serum creatinine
Time Frame
Each hour during 3 h after administration
Title
Plasma renin, aldosterone, norepinephrine, epinephrine, fludrocortisone, TNF alpha concentrations
Time Frame
Each hour during 3 h after administration
Title
Urinary electrolytes excretion
Time Frame
Each hour during 3 h after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over than 18 years old Septic shock Haemodynamic stability (mean arterial pressure between 70 and 80 mmHg) for at least 1 hour, with a norepinephrine dose less than 0,5 µg/kg/min Written informed consent Exclusion Criteria: Corticotherapy Known allergy to Fludrocortisone Esophageal or gastric disease Pregnant woman Inclusion in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno LAVIOLLE, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric BELLISSANT, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Service de Réanimation Chirurgicale - Hôpital de Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

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Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response in Septic Shock

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