Septic Shock Clinical Trial
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.
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).
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)
;
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