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

Septic Shock Clinical Trial

— FLUDRO  

Official title:

Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response, Gastric Mucosal Perfusion and Arterial Stiffness in Septic Shock

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02069288
• Other study ID #: EudraCT 2007-007971-18
• Secondary ID: CIC0203/082
• Status: Withdrawn
• Phase: Phase 3
• First received: December 23, 2013
• Last updated: February 19, 2014
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Fludrocortisone
50 µg of fludrocortisone per os
• Placebo
1 tablet of placebo per os

Locations

Country	Name	City	State
France	Service de Réanimation Chirurgicale - Hôpital de Pontchaillou	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Norepinephrine-mean arterial pressure dose-response relationship		1.5 h after administration	No
Secondary	Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances		During 3 h after administration	No
Secondary	Central aortic pressures, Augmentation Index (Aix).		During 3 h after administration	No
Secondary	Arterial stiffness: Carotid-femoral Pulse Wave Velocity		During 3 h after administration	No
Secondary	Humeral diameter and distensibility		During 3 h after administration	No
Secondary	Gastric mucosal perfusion		During 3 h after administration	No
Secondary	Plasma electrolytes, blood glucose, serum creatinine		Each hour during 3 h after administration	No
Secondary	Plasma renin, aldosterone, norepinephrine, epinephrine, fludrocortisone, TNF alpha concentrations		Each hour during 3 h after administration	No
Secondary	Urinary electrolytes excretion		Each hour during 3 h after administration	No