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

Information source: Rennes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Septic Shock

Intervention: Fludrocortisone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Rennes University Hospital

Official(s) and/or principal investigator(s):
Bruno LAVIOLLE, MD, Principal Investigator, Affiliation: Rennes University Hospital
Eric BELLISSANT, MD, PhD, Study Chair, Affiliation: Rennes University Hospital

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.

Clinical Details

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

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

Primary outcome: Norepinephrine-mean arterial pressure dose-response relationship

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Service de Réanimation Chirurgicale - Hôpital de Pontchaillou, Rennes 35033, France
Additional Information


Last updated: February 19, 2014

Page last updated: August 23, 2015

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