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
Summary
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
injection)
- 4 to 6 hours after third injection
- 4 to 6 hours after fourth injection (optional)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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