DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Effect of Hydrocortison on Post-ischemic Flow-mediated Dilation and on Thenar Oxygen Saturation in Human Septic Shock.

Information source: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Septic Shock; Adult

Intervention: hydrocortison hemisuccinate (Drug); placebo followed by hydrocortisone hemisuccinate (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Centre Hospitalier Régional d'Orléans

Official(s) and/or principal investigator(s):
Thierry Boulain, MD, Principal Investigator, Affiliation: Centre Hospitalier Régional d'Orléans, France

Overall contact:
Thierry Boulain, MD, Email: thierry.boulain@chr-orleans.fr


The main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8 hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between post-ischemic flow-mediated dilation (FMD) of the brachial artery (assessed by ultrasound imaging) and post-ischemic recovery slope of the thenar oxygen saturation (StO2) (assessed by near-infrared spectroscopy).

Clinical Details

Official title: Effect of Intravenous Hydrocortison on Post-ischemic Brachial Artery Dilation and on Thenar Oxygen Saturation in Adult Septic Shock. A Human Placebo-controlled Randomized Study.

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: Vasoreactivity

Detailed description: Two primary end points, considered as reflecting vasoreactivity will be assessed : 1. Flow-mediated dilation (FMD) of the brachial artery, measured by ultrasound imaging, expressed in mm or in percentage, will be calculated from artery diameters measured before and after a vascular occlusion test (cuff around arm or forearm). 2. recovery slope of thenar oxygen saturation (StO2), assessed by near infrared spectroscopy (NIRS), expressed in %/second, will be recorded after the vascular occlusion test. The two primary end points (FMD and recovery slope of StO2)will be assessed at the following timepoints :

- baseline (before first injection of placebo or hydrocortison)

- 2 hours after first injection of placebo or hydrocortison

- 2 hours after second injection of placebo or hydrocortison (i. e. 8 hours after first


- 4 to 6 hours after third injection

- 4 to 6 hours after fourth injection (optional)


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


Inclusion Criteria:

- age over 18 yrs

- consent obtained

- septic shock (according to international definition)

- patient sedated and submitted to invasive mechanical ventilation

- no need for surgery expected within 24 hours after enrollment

- patient has received at least one dose of large spectrum antibiotics

- superior vena cava catheter in place

- patient carrying a thermodilution device for cardiac output measurement

- stable mean arterial pressure within 65-5 mmHg limits for at least 2 hours;

Exclusion Criteria:

- pregnancy

- age below 18 years

- patient treated with iv continuous epinephrine

- chronic occlusive arteriopathy of the upper limbs

- regular or recent treatment with glibenclamide or glipizide

- regular or recent treatment with steroids

- known surrenal insufficiency

Locations and Contacts

Thierry Boulain, MD, Email: thierry.boulain@chr-orleans.fr

Centre Hospitalier Régional d'Orléans, Orléans 45000, France; Recruiting
Thierry Boulain, MD
Johann Le Drogoff
Thierry Boulain, MD, Principal Investigator
Additional Information

Starting date: November 2013
Last updated: July 30, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017