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

NCT02069288 | Withdrawn Phase 3

• 2 other identifiers: EudraCT 2007-007971-18CIC0203/082
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

fludrocortisone; pharmacology; septic shock

Outcome Measures

Primary Outcomes (1)

• Norepinephrine-mean arterial pressure dose-response relationship

  1.5 h after administration

Secondary Outcomes (8)

• Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances

  During 3 h after administration

• Central aortic pressures, Augmentation Index (Aix).

  During 3 h after administration

• Arterial stiffness: Carotid-femoral Pulse Wave Velocity

  During 3 h after administration

• Humeral diameter and distensibility

  During 3 h after administration

• Gastric mucosal perfusion

  During 3 h after administration

Study Arms (2)

1

EXPERIMENTAL

Fludrocortisone

Drug: Fludrocortisone

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Fludrocortisone DRUG

50 µg of fludrocortisone per os

Also known as: 9- alpha- fluorohydrocortisone

1

Placebo DRUG

1 tablet of placebo per os

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Corticotherapy
• Known allergy to Fludrocortisone
• Esophageal or gastric disease
• Pregnant woman

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Service de Réanimation Chirurgicale - Hôpital de Pontchaillou

Rennes, 35033, France

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Fludrocortisone

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Hydrocortisone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: February 24, 2014
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 24, 2014

Record last verified: 2014-02

Locations

FR (1)