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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01817153

Acronym

HyStOON

Enrollment

Registered

2013-03-22

Start date

2013-11-05

Completion date

2019-11-05

Last updated

2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult, Septic Shock

Brief 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)

Interventions

DRUGhydrocortison hemisuccinate

DRUGplacebo followed by hydrocortisone hemisuccinate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Vasoreactivity	every 6 hours over the first 24 hours of intervention

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026