NCT01817153

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.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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)

Conditions

• Septic Shock
• Adult

Interventions

Type	Name	Description
DRUG	hydrocortison hemisuccinate
DRUG	placebo followed by hydrocortisone hemisuccinate

Timeline

• Start date: 2013-11-05
• Primary completion: 2019-11-05
• Completion: 2019-11-05
• First posted: 2013-03-22
• Last updated: 2020-02-11

Locations

1 site across 1 country: France