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

Phase 3

Withdrawn

• Conditions: Septic Shock
• Interventions: Drug: Placebo; Drug: Fludrocortisone

• Registration Number: NCT02069288
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-23
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted QC: 2014-02-19
• Last Update Submitted: 2014-02-19
• Study First Posted: 2014-02-24
• Last Update Posted: 2014-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Fludrocortisone	Fludrocortisone

Primary Outcome Measures

Name	Time	Method
Norepinephrine-mean arterial pressure dose-response relationship	1.5 h after administration

Secondary Outcome Measures

Name	Time	Method
Central aortic pressures, Augmentation Index (Aix).	During 3 h after administration
Humeral diameter and distensibility	During 3 h after administration
Plasma electrolytes, blood glucose, serum creatinine	Each hour during 3 h after administration
Plasma renin, aldosterone, norepinephrine, epinephrine, fludrocortisone, TNF alpha concentrations	Each hour during 3 h after administration
Urinary electrolytes excretion	Each hour during 3 h after administration
Arterial stiffness: Carotid-femoral Pulse Wave Velocity	During 3 h after administration
Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances	During 3 h after administration
Gastric mucosal perfusion	During 3 h after administration

Trial Locations

Locations (1)

Service de Réanimation Chirurgicale - Hôpital de Pontchaillou; 🇫🇷 Rennes, France