Status:
TERMINATED
Effect of Hydrocortison on Post-ischemic Flow-mediated Dilation and on Thenar Oxygen Saturation in Human Septic Shock.
Lead Sponsor:
Centre Hospitalier Régional d'Orléans
Conditions:
Septic Shock
Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
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 percen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01817153
Start Date
November 5 2013
End Date
November 5 2019
Last Update
February 11 2020
Active Locations (1)
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1
Centre Hospitalier Régional d'Orléans
Orléans, France, 45000