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

Septic Shock Clinical Trial

— HyStOON  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01817153
• Other study ID #: CHRO-2012-04
• Secondary ID: 2012-004736-39
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: November 5, 2013
• Est. completion date: November 5, 2019

Study information

• Verified date: February 2020
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 5, 2019
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• hydrocortison hemisuccinate

• placebo followed by hydrocortisone hemisuccinate

Locations

Country	Name	City	State
France	Centre Hospitalier Régional d'Orléans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vasoreactivity		every 6 hours over the first 24 hours of intervention