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

• Status: Terminated
• Trial end date: 2019-11-05
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Régional d'Orléans
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

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