Clinical trial NCT01817153: Effect of Hydrocortison on Post-ischemic Flow-mediated Dilation and on Thenar Oxygen Saturation in Human Septic Shock.
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Septic Shock
Adult
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: Vasoreactivity
timeFrame: every 6 hours over the first 24 hours of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans
Study officials:
affiliation: Centre Hospitalier Régional d'Orléans, France
name: Thierry Boulain, MD
role: PRINCIPAL_INVESTIGATOR
References: