MedTrace Logo

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

NCT02069288 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-02-24

No results posted yet for this study

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

Interventions

DRUG

Fludrocortisone

50 µg of fludrocortisone per os

DRUG

Placebo

1 tablet of placebo per os

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Bruno LAVIOLLE, MD · Rennes University Hospital

  • Eric BELLISSANT, MD, PhD · Rennes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02069288 on ClinicalTrials.gov