Trial | NCT01817153  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    urea hydrocortisone ...

  • Study Participants

    10
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 :

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).
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)
Study Started
Nov 05
2013
Primary Completion
Nov 05
2019
Study Completion
Nov 05
2019
Last Update
Feb 11
2020

Drug hydrocortison hemisuccinate

Drug placebo followed by hydrocortisone hemisuccinate

placebo Placebo Comparator

10 mL normal saline iv at H0 and H6 (2 first injections blinded), followed by hydrocortison (open label) 50 mg iv at H8, H14 and H20

hydrocortison Active Comparator

50 mg hydrocortison iv at H0 and H6 (2 first injections blinded), followed by hydrocortison (open label) 50 mg iv at H12, H18 and H24

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
No Results Posted